Ergonomic and adjustable respiratory mask assembly with headgear assembly

ABSTRACT

A respiratory mask assembly for delivering breathable gas to a patient includes a frame having a main body and a side frame member provided on each lateral side of the main body. Each side frame member includes an integrally formed first connector portion. A headgear assembly is removably attachable to the frame. The headgear assembly has a second connector portion adapted to be removably coupled with the first connector portion provided on the frame. The second connector portion is manually movable to a releasing position to detach the headgear assembly from the frame. The headgear assembly is rotationally adjustable with respect to the frame.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present This application is a continuation of U.S. application Ser.No. 11/390,239, filed Mar. 28, 2006, currently pending, which is acontinuation of U.S. application Ser. No. 11/124,251, filed May 9, 2005,now U.S. Pat. No. 7,047,972, which is a continuation of U.S. applicationSer. No. 10/390,681, filed Mar. 19, 2003, now U.S. Pat. No. 6,907,882,which claims priority from Australian Application No. PS 1926, filedApr. 23, 2002 and claims the benefit of U.S. Provisional ApplicationNos. 60/377,254, filed May 3, 2002, 60/397,195, filed Jul. 22, 2002 and60/402,509, filed Aug. 12, 2002, each incorporated herein by referencein its entirety.

FIELD OF THE INVENTION

The invention relates to a nasal mask for use in the delivery ofNon-invasive Positive Pressure Ventilation (NPPV) and for nasalcontinuous positive airway pressure (nasal CPAP) therapy of sleepdisordered breathing (SDB) conditions such as obstructive sleep apnea(OSA).

BACKGROUND OF THE INVENTION

The application of nCPAP for treatment of OSA was taught by Sullivan inU.S. Pat. No. 4,944,310, incorporated herein by reference in itsentirety. In nCPAP treatment of OSA, pressurized air or other breathablegas is provided to the entrance of a patient's airways at a pressureelevated above atmospheric pressure, typically in the range 4 to 20 cmH2O to “splint” open the patient's upper airways and prevent apneas.

Apparatus to deliver nasal CPAP and NPPV therapy typically comprises ablower, an air delivery conduit and a patient interface. The blower maybe programmed to deliver a range of different forms of therapy. In oneform, a constant pressure of air or breathable gas is provided to thepatient. It is also known for the level of treatment pressure to varyfrom breath to breath in accordance with patient need, that form oftreatment being known as automatically adjusting nasal CPAP treatment asdescribed in U.S. Pat. No. 5,245,995 (Sullivan and Lynch), incorporatedherein by reference in its entirety. NPPV is another form of treatmentfor breathing disorders. In its most basic form, a relatively higherpressure of gas may be provided in the patient mask during theinspiratory phase of respiration and a relatively lower pressure oratmospheric pressure being provided in the patient mask during theexpiratory phase of respiration. In other modes, the pressure can bemade to vary in a complex manner throughout the respiratory cycle. Forexample, the pressure at the mask during inspiration or expiration canbe varied through the period of treatment. See, for example, U.S. Pat.No. 5,704,345 and International Patent Publication Nos. WO98/12965 andWO99/61088, all of which are incorporated by reference herein in theirentireties. In this specification, the term NPPV therapy will be used todescribe all these forms of NPPV and nasal CPAP therapy.

The patient interface for NPPV therapy may take many forms, such as anasal mask assembly, a nose and mouth mask assembly, nasal cushions or anasal prongs or pillows assembly. A mask assembly typically includes arigid shell, a soft face-contacting cushion, a forehead support andheadgear for securing the mask to the head.

In one known mask assembly, the headgear includes a cap portion withfour straps. In use, the cap portion engages the occipital portion ofthe patient. Furthermore, in use, the two lower straps extend betweenthe cap portion and a nasal mask while the two upper straps extendbetween the cap portion and a forehead support. See, for example, U.S.Pat. No. 6,119,693 (Kwok, Matchett and Grant), incorporated herein byreference in its entirety.

Some patient interfaces include quick or convenient release mechanismsfor enabling a patient and/or clinician to disengage from the blower,blower tube and/or the mask/headgear assembly. Quick or convenientrelease mechanisms are useful where NPPV therapy needs to be temporarilyinterrupted or where a system failure causes a cessation of gas flow tothe patient interface. For example, as disclosed in U.S. patentapplication Ser. No. 09/482,718, incorporated herein by reference in itsentirety, the headgear and mask can be removed from the patient bypulling a conveniently located cord to decouple hook and loop fastenersbetween engaging headstraps that are positioned, for example, at therear of the headgear assembly. In another example, as disclosed in U.S.patent application Ser. No. 09/504,220, incorporated herein by referencein its entirety, the headgear/mask assembly can be removed from thepatient by detaching a connector member for the headstrap, whichconnector member is connected directly to the frame of the mask. Seealso U.S. Pat. No. 3,990,727, which discloses a quick detachable couplerthat appears to be employed by the SleepNet™ IQ™ mask.

Since the patient must be able to sleep while wearing the patientinterface, it is desirable that it be comfortable. In addition, thepatient interface should provide a good seal to prevent or reduce leaks,or to better control any leak that occurs and to maintain efficacy oftreatment. Since the shape of people's noses, faces and heads varywidely, from a commercial perspective, it is important to be able tomanufacture patient interfaces which can accommodate this range offacial shapes without having to carry excessive inventory through alarge number of sizes. A number of patient interfaces have been designedwith the goals of patient comfort, ease of use, adjustability and theability to accommodate a wide range of patient face and head shapes inmind.

U.S. Pat. No. 5,243,971 (Sullivan and Bruderer) provides a patientinterface (both nasal and full-face masks) that is suitable for use inNPPV therapy. The mask has a face contacting portion mounted to a shellwhich is sized and shaped to overfit the nose region of an intendedwearer, and the face contacting portion is in the form of a distendablemembrane which is molded from an elastic material. U.S. Pat. No.5,243,971 is hereby incorporated by reference in its entirety.

U.S. Pat. Nos. 6,357,441 and 6,112,746 (Kwok and Styles) each describe anasal cushion which comprises a substantially triangularly shaped framefrom which extends a membrane. These patents are hereby incorporated byreference in their entirety.

Other nasal masks are disclosed in U.S. Pat. Nos. 5,724,965 and6,119,694, incorporated by reference in their entirety. Each describes anasal cushion that engages with the tip of the nose or that portion ofthe nose in the horizontal plane just above the upper lip of thepatient. In PCT/US00/11329 (WO 00/69521), incorporated by reference inits entirety, a triangular-shaped nasal cushion includes a taperedprofile that narrows towards the face of the patient. Some of theseprior art masks/cushions has experienced significant challenges from theperspective of patient comfort, potential nasal vent occlusion,stability and/or sealing (especially at the nasal bridge and cheekregions).

A number of adjustable forehead supports have been developed with theaim of achieving a serviceable seal while increasing patient comfort andaccommodating the greatest number of patients in the population. Forexample, U.S. Pat. No. 6,119,693 (Kwok, Matchett and Grant) describes anadjustable forehead support for a nasal mask or full-face mask. Theforehead support may be adjusted for the different shapes and sizes of afacial profile. The angle of the seal relative to the face may beadjusted with this invention. U.S. Pat. No. 6,119,693 is herebyincorporated by cross-reference in their entirety. In InternationalPatent Application PCT/AU00/00097 (WO 00/78384), a forehead support isdisclosed that is adapted to be secured to a respiratory mask.International Patent Application PCT/AU00/00097 (WO 00/78384) is herebyincorporated by cross-reference in its entirety.

Accordingly, a need has developed in the art to provide a mask assemblythat is capable of overcoming the drawbacks or limitations of the priorart.

BRIEF SUMMARY OF THE INVENTION

One aspect of the present invention is directed towards a comfortablepatient interface for delivering NPPV therapy.

Another aspect of the invention is to provide a patient interface thatwill result in improved patient compliance with NPPV therapy.

It is another aspect of the present invention to create a cushion thatis capable of sealing on a smaller area of the nose as compared to knownmasks, while retaining or exceeding the comfort level of the ResMedMirage® and Ultra Mirage® cushions.

It is a further aspect of the present invention to reduce the perceivedand/or actual size and/or weight of a nasal mask and provide a lessintrusive mask for the user.

Another aspect of the present invention is to provide a mask assembly inwhich the mask and headgear have a reduced amount of connections thatare provided in a convenient and intuitive location for quick attachmentand/or detachment by the patient, while not being easily detachedaccidentally.

Another aspect of the invention is to provide a mask assembly in whichit is not necessary to provide a forehead support or an adjustmentmechanism for the forehead support, while maintaining stability of themask in use.

Another aspect is to provide a nasal mask capable of fitting a widerange of patients, so as to decrease or minimize inventory requirementsand the number of differently sized masks/cushions that are required forproduction.

Yet another aspect of the present invention is to provide a nasal maskthat offers more comfort to the patient, e.g., by better avoiding theapplication of unwanted localized pressure points in the facialcontacting regions especially to the sensitive nasal bridge region ofthe patient, while maintaining a good seal, with or without theassistance of positive pressure to form or maintain the seal. Anotheraspect of the present invention is to avoid contact with the upper nasalbridge region, while avoiding localized pressure points along the lowernasal bridge region where the bony portion transitions into a portion ofthe nose containing more cartilage.

Another aspect of the present invention is to avoid application ofunwanted localized contact pressure or forces that may increaseundesirably the impedance of airflow through the patient's nares/narisand nasal passages, especially through the nasal vent.

Still another aspect is to provide a headgear assembly which can provideadded stability to the mask/cushion assembly. In embodiments, theheadgear may be made of or include at least one layer which imparts adegree of stiffness to the headstraps to assist in the stabilization ofthe mask/cushion assembly, which may obviate the need for a foreheadsupport and thereby decrease visual obstructions near the patient's eyesand better enhance or at least not hinder the patient's ability to don,wear or remove eye glasses with the mask system in use. At least aportion of the headstrap itself may be formed of a relatively more rigidmaterial in comparison to relatively flexible headstraps, instead ofproviding a multiple layer structure. The headgear may include arelatively large, hand-manipulable clip member that can be quickly andeasily attached and/or detached from the head strap and/or the maskframe. Alternatively, the headgear may be magnetically coupled with themask frame.

Another aspect of the present invention is to provide a convenient orquick release mechanism which requires little effort or dexterity tooperate.

Another aspect of the present invention is to provide a frame whichincludes and/or integrates a quick release mechanism so that the clipmember of the head straps can be easily detached from the frame. Thequick release mechanism may include at least one connector portionformed in one piece with the frame. A mating connector portion can beprovided on a portion of the headgear. The mask system is attached to asource of pressurized air which is delivered via an air deliveryconduit. The conduit may be directly attached to the mask with its lumenin fluid communication with the mask chamber in order to supplypressurized air to the entrance of the patient's airway. Preferably anintermediate piece connects the air delivery conduit to the mask.Preferably the intermediate piece is an elbow joint, which will bebetter described below. The frame may include an extended tubeprotruding from the outside surface of the mask, which can improve theseal between the elbow joint and the mask frame and also improve thestability of the connection between the mask frame and the elbow joint.The extended tube may include a flange for attachment to the elbowassembly. Preferably the elbow assembly may be easily manipulated toquickly and readily detach the elbow joint from the mask frame during atemporary interruption in patient treatment. The elbow assembly mayinclude a vent to atmosphere. Preferably the vent is in fluidcommunication with the system air path via an exhaust passage which isseparated from the incoming gas path, for example, by using a baffleprovided within a portion of the elbow joint.

Another aspect of the invention is to provide a generally trapezoidalshaped mask cushion for a patient interface.

Another aspect of the invention provides a respiratory mask assembly fordelivering breathable gas to a patient. The respiratory mask assemblyaccording to one embodiment includes a frame having a main body and aside frame member provided on each lateral side of the main body. Eachside frame member includes an integrally formed first connector portion.A headgear assembly is removably attachable to the frame. The headgearassembly has a second connector portion adapted to be removably coupledwith the first connector portion provided on the frame. The secondconnector portion is manually movable to a releasing position to detachthe headgear assembly from the frame. The headgear assembly isrotationally adjustable with respect to the frame.

Of course, portions of the described aspects of the present inventionmay form sub-aspects of the present invention. Also, various ones of thesub-aspects and/or aspects may be combined in various manners and alsoconstitute additional aspects or sub-aspects of the present invention.These and other features and aspects of the present invention will bedescribed in or be apparent from the detailed description below read inconjunction with the attached Figures, where like reference numeralsindicate like components.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 is a perspective view of a nasal mask assembly according to onepreferred embodiment of the present invention;

FIG. 1 b shows a headgear assembly according to an embodiment of theinvention;

FIG. 2 is a partial side view of the nasal mask assembly of FIG. 1;

FIG. 3 is a partial front view of the nasal mask assembly of FIG. 1;

FIG. 4 is a partial top plan view of the nasal mask assembly of FIG. 1;

FIG. 5 is a front perspective view of a frame component of the nasalmask assembly of FIG. 1;

FIG. 5 a is a top view of the frame of FIG. 5;

FIG. 5 b is a schematic view showing various forces acting on the nasalmask assembly which may affect a patient;

FIG. 5 c is a rear perspective view of the frame of FIG. 5;

FIG. 6 a is a top view of an elbow assembly and frame according toanother embodiment of the present invention;

FIG. 6 b is an exploded view of the embodiment of FIG. 6 a;

FIG. 7 is a partial sectional view of the frame of FIG. 5;

FIG. 8 is a side view of a left side yoke of the nasal mask assembly ofFIG. 1;

FIG. 8 a is an enlarged view of a right side yoke according to anotherembodiment of the present invention;

FIG. 9 a is a top view of a locking clip of the nasal mask assembly ofFIG. 1;

FIG. 9 b is a bottom view of the locking clip of FIG. 9 a;

FIG. 10 a is a side view of a clip and frame in a nearly fully connectedcondition, according to the present invention;

FIG. 10 b is a bottom view of the clip of FIG. 10 a;

FIG. 10 c is a top view of the clip of FIG. 10 a;

FIG. 10 d is a perspective view of the clip of FIG. 10 a;

FIGS. 10 e-10 g illustrate the clip and yoke of the present invention invarious connected positions;

FIG. 11 is a perspective view of a buckle of the nasal mask assembly ofFIG. 1;

FIG. 12 is a bottom view of a cross-over strap of the nasal maskassembly of FIG. 1 in a relaxed state;

FIG. 13 is a bottom view of the cross-over strap of FIG. 12 in acrossed-over state;

FIG. 14 is a view of a cross-over buckle of the cross-over strap of FIG.13;

FIG. 15 is a perspective view of a strap loop for use with the nasalmask assembly of FIG. 1;

FIG. 16 a is a perspective view of the swivel elbow shown in FIG. 1;

FIG. 16 b is a side view of a swivel elbow of the nasal mask assembly ofFIG. 1;

FIG. 17 is a front view of the swivel elbow of FIGS. 16 a and 16 b;

FIG. 18 is a rear view of the swivel elbow of FIGS. 16 a and 16 b;

FIG. 18 b is a side view of another embodiment of a swivel elbow;

FIG. 18 c is a front view of the swivel elbow of FIG. 18 b;

FIG. 18 d is a rear view of the swivel elbow of FIG. 18 b;

FIG. 18 e is a cross-sectional view of the swivel elbow of FIG. 18 b;

FIGS. 19 a-1-19 c-2 are sequential sectional views of the swivel elbowas shown in FIG. 18, illustrating connection with a flange extendingfrom the front surface of the frame;

FIG. 20 is a perspective view of a vent cover of the nasal mask assemblyof FIG. 1;

FIG. 21 is a rear view of the vent cover of FIG. 20;

FIG. 22 is a bottom view of the vent cover of FIG. 20;

FIG. 22 b is a perspective view of another embodiment of a vent coverfor connection with the swivel elbow of FIG. 18 b;

FIG. 22 c is a rear view of the vent cover of FIG. 22 b;

FIG. 22 d is a bottom view of the vent cover of FIG. 22 b;

FIG. 22 e is a side view of the vent cover of FIG. 22 b;

FIG. 22 f is a side view of illustrating the vent cover of FIG. 22 bconnected to the swivel elbow of FIG. 18 b;

FIG. 23 is a perspective view of a connector tube of the nasal mask ofFIG. 6 a;

FIG. 24 a is a face side view of a cushion of the nasal mask assembly ofFIG. 1 showing Computer Aided Design (CAD) construction lines;

FIG. 24 b is a frame side view of the cushion of FIG. 24 a showing CADconstruction lines;

FIGS. 24 c-24 f illustrate various perspectives of the cushion shown inFIG. 24 a;

FIG. 24 g shows a mask cushion in accordance with an embodiment of theinvention incorporating a septum notch;

FIG. 25 a is a perspective view of the cushion shown in FIG. 1 showingCAD construction lines;

FIG. 25 b is a face side view of the cushion of FIG. 25 a;

FIG. 25 c is a frame side view of the cushion of FIG. 25 a showing CADconstruction lines;

FIG. 25 d is a cross-section taken along line 25 d-25 d of FIG. 25 bshowing CAD construction lines;

FIG. 25 e is a cross-section taken along line 25 e-25 e of FIG. 25 b;

FIG. 25 f is a cross-section taken along line 25 f-25 f of FIG. 25 b;

FIG. 25 g is a cross-section taken along line 25 g-25 g of FIG. 25 b;

FIG. 25 h is a cross-section taken along line 25 h-25 h of FIG. 25 b;

FIG. 25 i is an enlarged view of FIG. 25 d showing typical (TYP)dimensions of an embodiment (R-radius);

FIG. 26 is a perspective view of an air tube of the nasal mask assemblyof FIG. 1;

FIGS. 27 a-27 e are partial sectional views of a frame and cushion ofthe nasal mask assembly of FIG. 1 showing a sequence of positions ofassembly and disassembly of the frame and cushion;

FIG. 28 is a partial sectional view of an alternative embodiment of theframe and cushion of the nasal mask assembly of FIG. 1;

FIGS. 29 a-29 d show alternative sealing configurations of the cushionof FIGS. 27 a-27 e.

FIGS. 30 and 31 show various dimensions used to design a mask accordingto FIG. 1;

FIGS. 32 a-1-32 c-2 illustrate an additional embodiment of the presentinvention for engagement between the frame and cushion, the cushionshowing CAD construction lines;

FIG. 32 d is an enlarged cross-sectional view of the frame shown inFIGS. 32 a-1-32 c-2;

FIG. 32 e illustrates an additional embodiment of the present inventionfor engagement between the frame and cushion;

FIG. 33 is a perspective view of another embodiment of a frame of thenasal mask assembly;

FIG. 34 is a top view of another embodiment of the yokes of the headgearassembly of the nasal mask assembly;

FIG. 35 is an enlarged view of a right side yoke of the headgearassembly shown in FIG. 34;

FIG. 36 is a perspective view illustrating the frame of FIG. 33magnetically coupled to the headgear assembly of FIGS. 34 and 35;

FIG. 37 is a schematic view illustrating the magnetic coupling of theframe of FIG. 33 and the headgear assembly of FIGS. 34 and 35;

FIGS. 38A-38D show various perspectives of another embodiment of thecushion, the cushion showing CAD construction lines;

FIGS. 39A-39D show various perspectives of another embodiment of thecushion, the cushion showing CAD construction lines;

FIG. 40 is a perspective view of another embodiment of a frame of thenasal mask assembly;

FIG. 41 is a bottom view of the frame shown in FIG. 40;

FIG. 42 is a top view of an embodiment of the cushion structured to beengaged with the frame shown in FIG. 40, the cushion showing CADconstruction lines; and

FIG. 43 is a rear view of the cushion shown in FIG. 42, the cushionshowing CAD construction lines.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Two main embodiments are described in the figures. Although many of thefeatures and/or parts of each embodiment are the same, there are severalparts and/or elements that are different. For example, while FIG. 1shows one embodiment of an elbow assembly 60 according to the presentinvention, FIGS. 6 a-6 b show another arrangement of the elbow assembly60. Other differences between the embodiments will be described below.Moreover, several alternative approaches are also described with respectto various parts and/or elements, and those alternative approachesshould be considered as additional preferred embodiments of the presentinvention.

As shown in FIGS. 1-4, a nasal mask assembly 10 according to onepreferred embodiment of the present invention includes a frame 20 and acushion 40 that is preferably detachably connected to the frame 20.Alternatively, the cushion 40 can be permanently attached to the frame20 using, e.g., co-molding or over-molding techniques, glue and/ormechanical fastening means. A swivel elbow assembly 60 and a headgearassembly 80 can be attached to the frame 20. FIG. 1 shows the nasal maskassembly 10 generally as it is intended to be mounted onto a human head.Of course, the depiction in FIG. 1 is slightly spaced away from thehead, or “floating”, for ease of understanding. FIG. 1 b shows theheadgear assembly laid flat with the frame 20 removed therefrom. FIG. 2illustrates the mask assembly 10 from the left side view, FIG. 3illustrates a front view thereof, and FIG. 4 illustrates a top viewthereof. In FIGS. 2-4, the rear portion of the headgear assembly 80 hasbeen removed for clarity.

Mask Frame

As shown in FIG. 5, frame 20 includes an elongated body 22 having acentral bore 24 for connecting to the swivel elbow assembly 60. FIG. 5 ais a top view of the frame 20 in which the cushion 40, the elbowassembly 60 and the headgear assembly 80 have been detached. The frame20 includes a main body 20 a, which is designed to accommodate thecushion 40, and a pair of side frame members 20 b that are preferablyformed in one piece with the main body 20 a of the frame 20. FIG. 5 ashows that both side frame members preferably have the sameconfiguration. The main body 20 a and the side frame members 20 b havebeen designed to have a curvature that generally follows the facialcontour of the patient's face on each side of the nose. In accordancewith one embodiment of the invention, the curvature follows a smoothtransition from the two side members having an inclusive angle of 120°.With the cushion 40 in place, the main body 20 a is spaced away from thepatient's face in the nose region to prevent contacting the patient'snose, while the side frame members 20 b are generally parallel the cheekregions. A space is maintained between each side frame member 20 b andthe cheek of the patient since contact is not desired in this area.However, if desired, the side frame members 20 b may be constructed toinclude a comfort feature such as pad structure that engages the cheekregions of the patient. Such a pad can have the advantage of assistingin supporting the cheeks when pressure is applied in treatment mode.

Based on the curved design of the frame 20, and other features, thecenter of gravity CG1 (FIG. 5 b) of the mask assembly 10 can be formedcloser to the face of the patient. As such, rotative torque or momentcreated in the vertical plane due, for example, to the weight of themask assembly can be reduced. For example, if the patient is sitting inthe upright position as shown in FIG. 5 b, the weight of the maskassembly 10 can produce torque about an axis A (into the page) that istransverse to the patient's nose in the horizontal plane. That torquecan produce forces tending to rotate the mask assembly 10 in thedirection of arrow B about the axis A which is generally positionedalong the upper lip region of the cushion. Such torque may result inpatient discomfort along the upper lip region and/or reduced sealingaround the lower bridge region of the nose and/or at the cheek region.Specifically, a center of gravity CG1 located close to the face canproduce less torque than a mask having a center of gravity CG2 that isfurther away from the face. This is because the distance d1, d2 betweenthe center of gravity CG1, CG2 and the face defines the lever arm usedto measure torque (torque=force×lever arm distance). Accordingly, torquecan be reduced if the force or the lever arm distance is reduced.Similar torques can be created if the patient is lying on his or herside as well. The torque is affected by the geometry of the elbow,including such features as its length and height in relation to thecushion. It is desirable to minimise the effective lever arm length ofthe assembly which depends amongst other things on the configuration ofthe elbow.

Other factors which contribute towards reducing the distance between thecenter of gravity of the mask assembly and the face include design ofthe cushion 40, the design of the frame 20, and the design of the elbowassembly 60. Another source of torque, which may affect stability of themask, is the connection of the elbow assembly 60 to the gas deliverytube. In effect, the gas delivery tube may impart a force on the elbowassembly 60, which in turn may create a torque tending to shift the maskassembly with respect to the patient. The amount of torque applied tothe patient due to the connection between the elbow assembly and the gasdelivery tube can be reduced using the elbow assembly 60 discussed belowin relation to FIGS. 16 a-19 c-2. In short, the lever arm of the elbowassembly can be effectively reduced because the elbow assembly isdesigned to be connected directly to a gas delivery tube 310 (FIG. 26),without the need for an intermediate swivel connector member 300 (FIGS.6 b and 23) between the elbow assembly and the gas delivery tube 310, asis currently used in some prior art. Alternatively, a swivel may beincorporated within the tube. In this way, an additional degree offreedom of movement may be added without increasing the undesirabletorque. Also, because the cushion 40 is designed to distribute pressureat least along the lip and cheek regions of the cushion 40, thepossibility or tendency to rotate in the vertical plane is furtherreduced. Moreover, each of the cheek regions of the cushion 40 defines arelatively large contact pressure receiving surface that is elongated inthe vertical direction and widened in the horizontal direction. As suchthe cushion 40, at least in the cheek regions, resist rotationalmovement in the vertical and/or horizontal planes, which helps maintainthe cushion 40 in a consistent position on the patient. More details ofthe cushion 40 are described below in relation to FIGS. 24 a-25 i.Referring to FIG. 5 c, the frame 20 includes a channel 26 having agenerally trapezoidal shape for connecting to the cushion 40. Thechannel 26 includes an inner wall 28, an outer wall 30 and a channelfloor 32. The channel 26 will be described in further detail below.

FIG. 6 a shows a frame 20 and elbow assembly 60 that is slightlydifferent than the frame 20 and elbow assembly 60 shown in FIGS. 1-5 c.Although the main differences between the embodiments reside in theelbow assembly 60, there are other differences between the frames 20,cushions 40, etc., as will be readily seen by comparing the variousfigures, or understood in conjunction with the description in varioussections below. Like elements are indicated with like reference numbers.

In FIGS. 6 a and 6 b, the elbow assembly 60 is attached to the mask 20using a C-clip 23 (FIG. 6 b) that can be expanded and contracted to fitwithin a circumferal groove 25 provided on a portion of the elbowassembly 60 that protrudes into the frame 20 using a mechanism similarto that provided on ResMed's ULTRA MIRAGE® mask and as described in U.S.patent application Ser. No. 09/594,775 (Drew et al.). An exploded viewof the cushion 40, the frame 20, the elbow assembly 60 and the gasdelivery tube is shown in FIG. 6 b. The C-clip 23 has a surface thatengages the inside surface of the frame 20 to prevent unwanteddisconnection between elbow assembly 60 from the frame 20. The elbowassembly 60 may also include one or more vent openings 61 open toatmosphere, for example, for gas washout of exhaled carbon dioxide,among other things. The vent openings 61 are structured so thattreatment pressure will be maintained within the nasal cavity. The ventopenings 61 may be covered with a shell member 65 which is resilientlyand removably clipped onto an outer surface of the elbow assembly 60.The vent openings 61 in FIG. 6 a are visible through the clear shellmember 65. Details of the shell member 65 and the C-clip are describedin the ResMed's U.S. patent application Ser. Nos. 09/502,745, 09/594,775or PCT Application No. PCT/AU00/00097 (WO 00/78384), all of which areincorporated herein by reference.

As shown in FIG. 6 a, the inner wall 28 of channel 26 preferably extendsaway from the frame 20 to a distance that is greater than the distancethat the outer wall 30 extends away from the frame 20. FIGS. 5 c and 32d also show that the inner wall 28 extends away from the frame 20 adistance that is greater than the distance over which the outer wall 30extends away from the frame 20. As shown in FIG. 32 d, the thickness ofthe inner wall 28 is in the range of about 1-2 mm, preferably 1.4 mm,the thickness of the outer wall 30 is in the range of about 1-2 mm,preferably 1.4 mm, and the distance between the tops of the inner andouter walls 28, 30 is in the range of 0.5-10 mm, preferably 2 mm.Further, as shown in FIG. 32 d, the width of channel 26 between theupstanding surfaces of the inner and outer walls 28, 30 that face eachother is in the range of about 2-10 mm, preferably 5 mm.

By adopting this relative distance between inner wall 28 and outer wall30, the engagement of the cushion 40 to the frame 20 is facilitated. Asthe cushion and mask frame are moved together, the inner wall 28provides a visual and/or tactile cue to cushion alignment and then willfacilitate the continuance of the engagement process by guiding the edgeof the side wall or central portion 215 (FIGS. 24 e and 27 a) of thecushion 40 into channel 26, as will be more fully explained withreference to FIGS. 27 a-29 d and 32 a-1-32 c-2. The shape of the channel26, e.g., a generally trapezoid shape as seen in FIG. 5 c, is selectedso as to achieve guidance to correct cushion orientation relative to thechannel 26 without the need for additional guide pieces as would be thecase should the channel 26 have a more symmetrical shape such as anequilateral triangle, circle, square or rectangle. Nevertheless, thecushion channel 26 could adopt any of these shapes.

As seen in FIGS. 5 c and 6 a, the frame 20 includes a locking clipreceiver assembly 34 positioned on each side of the frame 20 forconnecting to a respective locking clip 82 (FIGS. 9 a and 10 a) of theheadgear assembly 80. Each locking clip receiver assembly 34 includes anengagement face 35 (FIG. 5 c), a central support slot 36 and two lockingslots 38 positioned on opposite sides of the central support slot 36.The central support slots 36 and locking slots 38 have a generallyrectangular cross-section. Each of the locking slots 38 includes alocking flange 39 (FIG. 7) positioned on an outer wall thereof forengagement with a respective locking tab 116 (FIGS. 9 a and 9 b) of oneof the locking clips 82, as described below. The channel 38 may beprovided with a slot 71 (FIG. 10 a) in the outer wall of the frame 20 inaddition to or in replacement of the locking flange 39 (FIG. 7). Theslots 71 on the bottom of the frame 20 can be seen in FIG. 5 a, whileFIG. 4 shows the slots 71 from the top of the frame 20. The slots 71need not extend through the side walls of the frame 20.

Headgear Assembly

FIG. 1 b shows headgear assembly 80 in accordance with an embodiment ofthe invention, without the frame 20 or cushion 40. In FIG. 1 b, theheadgear assembly is shown laid flat.

The Straps and Yokes

Referring to FIGS. 1-4, headgear assembly 80 includes a pair of frontstraps 84, with the left and right front straps 84 preferably beingmirror images of each other. Each front strap 84 is in the general formof a “Y” and has a front strap end 86, a top strap end 88 and a rearstrap end 90 all formed in one piece or otherwise interconnectedtogether by mechanical fastening or the like. The straps are made fromlaminated fabric and foam. One commercially available material is“Breath-O-Prene”™ manufactured by Accumed Inc., USA. Fastening of thestraps may be assisted by use of a hook and loop material such asVELCRO®, however, the straps need not include hook and loop fastenerssince the straps are fastened to the frame 20 using locking clips 82, asmore fully described below. As shown in FIGS. 1-3 and 8, a yoke 92 isattached to each front strap 84. Each yoke 92 has the same general shapeas the corresponding front strap 84 and has a front end 94, a top end 96and a rear end 98. Each yoke 92 is constructed of a somewhat rigidmaterial, e.g., plastic, and has a thickness in the range of 0.3-2.0 mm,preferably 1 mm. Examples of the plastic include nylon 11 orpolypropylene. The yoke 92 is attached to the corresponding front strap84 with adhesives, stitching, or other known attachment mechanisms. Thestrap and yoke arrangement can have different flexibilities in differentdirections, for example being stiff in a first direction (e.g., toresist the deformation due to the weight of the swivel elbow, associatedconduits, etc.), but flexible in a direction generally orthogonal to thefirst direction. Upon donning the mask on the user's head, the relativestiffness of the yokes helps position the frame and cushion in thecorrect position on the user. Although having the same general shape asthe front straps 84, the top ends 96 and rear ends 98 in this embodimentdo not extend as far as the top strap ends 88 and rear strap ends 90 ofthe front straps 84. However, in another embodiment, the top end 96 maybe extended along the entire length of the top strap 88 and be formedintegrally or in one piece with a connector element 128 (FIG. 1). Theyokes 92 are also narrower than the front straps so that when they areattached together, the softer material of the front straps 84 extendsbeyond the more rigid material of the yokes 92, thereby preventing or atleast reducing the opportunity for contact between the user and the morerigid material of the yokes 92 that could cause irritation ordiscomfort. While the straps and associated yokes are formed from amultilayer construction, e.g., two layers, the strap 84 and yoke 92could be formed of a single material, so long as patient comfort and theappropriate rigidity/flexibility are maintained.

The yokes 92 add to the rigidity of the straps 84 in certain planes anddirections, which assists in stabilizing the mask assembly 10 on thehead of the patient during use. In other planes and directions, the yokeand strap assembly has a different rigidity. For example, the strap andyoke should be able to resist bending or curling towards or away fromthe patient's face. In general, the strap 84 and yoke 92 should be ableto maintain their positions with respect to the head of the patient whenthe straps 84 and yokes 92 are connected to the frame 20. Moreover, themask frame 20 need not be provided with a forehead support assembly,which may further increase the comfort of the patient since thepatient's field of view is less obstructed as compared to masks withforehead supports. Of course, forehead supports of the type describedabove may be provided if desired for additional stability or comfort.Also, the mask frame 20 need not be provided with a chin strap, althougha chin strap may be provided if desired for additional stability orcomfort. In addition, beyond removal of the forehead support, the shapesof the straps 84 and yokes 92 are selected to avoid interference withthe patient's field of view. In particular when fitted, the front ends94 of each yoke 92 are connected to the frame 20 below the patient'seyes, and preferably extend along a curved arc resting across the cheekregions. The top end 88 of each strap 84 and the top end 96 of each yokeextend away from the intersection of the Y along the temple region ofthe patient's head. The rear end 98 of the yoke 92 and the rear end 90of the strap 84 are curved downwardly and around the ear of the patientfor connection with the rear strap member 138, as more fully describedbelow. Due to the rigidity provided by the yokes 92, the straps 84 arebetter able to maintain a predetermined shape. On the other hand, acertain degree of flexibility of the yoke 92 and strap 84 is providedsuch that variations in patient physiology can be accommodated to acertain degree. The thickness of the yoke can also vary across itsprofile to modify flexibility characteristics, for example, thickerregions may be stiffer.

As shown in FIG. 8, each yoke 92 has a mounting flange 100 positioned onthe front end 94. The mounting flange 100 has an aperture or keyhole 101leading to a bore 103, see FIG. 8 a. Two semi-annular flanges 102 areseparated from each other by slots 104. A radial inner surface of thesemi-annular flanges 102 forms the central bore 103. The yoke 92 alsohas a spring tab 106 positioned rearward of the mounting flange 100 witha front portion of the spring tab connected to the yoke 92 and a rearportion separated from the yoke 92 by space 107 to be able to flex withrespect to the yoke 92 when pressure is applied to the spring tab 106.The spring tab 106 preferably has a plurality of raised teeth 108positioned in an arc about an axis of the mounting flange 100. Thespring tab 106 also has a textured surface 110 (FIG. 8) or a raisedpositioning member 110 a (FIG. 8 a) at its free end to assist the userin locating, engaging and manipulating the spring tab 106. FIG. 8 a isan enlarged view of a right side yoke 92 and strap 84, like that shownin FIG. 8, to better show details of yoke 92, including the manner inwhich the yoke 92 is stitched to the head strap 84. Other fixingmechanisms such as locking or friction may be used.

The Locking Clip

The locking clip 82 is adjustably attached to each mounting flange 100.As shown in FIGS. 9 a and 9 b, each locking clip 82 includes a main body112. Two spring arms 114 are attached to opposite sides of the main body112 and extend away from the main body in a generally parallel manner. Alatch hook 116 is attached to a free end of each spring arm 114.

As shown in FIG. 10 a, the clip 82 can be inserted into releasableengagement with the locking clip engagement receiver 34 of the frame 20.In FIG. 10 a, only one clip 82 is shown and the clip 82 is not assembledto the yoke 92. Each latch hook 116 is received within a respectivechannel 38 (FIG. 5 c) of the frame. In FIG. 10 a, the distal ends of thelatch hooks 116 are shown in a position just before they outwardly flexinto the respective recesses 71 of the channel 38. FIG. 4 shows thedistal ends of the latch hooks in the engaged position within therecesses 71. Of course, the clip 82 or at least the latch hook 116thereof could be formed in the frame 20, and the channel 38 or at leastthe recess 71 could be formed on the strap and/or yoke.

FIGS. 4 and 10 a also show that the outward surfaces of the locking clip82 and the frame 20 preferably form a generally continuous surface,which is not interrupted when connected. Preferably, the locking clip 82is as wide as the frame 20 at each end, which facilitates tactilelocation of the locking clip by the patient. The spring arms 114 aredesigned to flex within the plane of the locking clip main body, whichfurther improves the ease by which the locking clips 82 are attached anddetached. This positioning improves the ergonomics of the releasemechanism. The patient's thumb and an opposing finger can be used toreadily locate and operate the locking clips 82. Also, because of theirincreased size, patients with minimal dexterity can operate the lockingclips 82. Further, the locking clips 82 are connected to the strap84/yoke 92 so that length adjustment between the locking clips 82 andthe strap 84/yoke 92 is not necessary.

The locking clip 82 includes a retaining flange 118 (FIG. 9 b) extendingtransversely outward from the main body 112. The retaining flange 118has a central hub 119 extending along an axis of the retaining flange118 and two retaining tabs 120 extending transversely from the centralhub 119 on opposite sides of the central hub 119. FIGS. 10 b-d show moredetails of the locking clips 82 shown in FIG. 10 a, which are similar tofeatures shown in FIGS. 9 a and 9 b. While the locking clip 82 has beenshown to be separate from the yoke 92, it is understood that the clipand yoke 92 could be formed in one piece if relative movement and/ordetachment between the two is not required. Conversely, the clip 82 andframe 20 can be formed as an integral unit, and the clip portion couldbe connected to the yoke.

The retaining flange 118 is sized and shaped such that the retainingtabs 120 can be aligned with the slots 104 and the retaining flange 118axially inserted into the mounting flange 100 of the yoke 92. Thecentral hub 119 is sized to have a close tolerance with the central bore103 so that the locking clip 82 and yoke 92 are rotationally supportedwith one another. Once the retaining flange 118 has been inserted intothe mounting flange 100, the locking clip 82 can be rotated with respectto the yoke 92 such that the retaining tabs 120 engage an inside surfaceof the flanges 102, thereby axially locking the mounting clip 82 to theyoke 92. FIGS. 10 e-g show the locking clip 82 in various positions withrespect to the yoke 92. In FIG. 10 e, the tabs 120 of the clip 82 havebeen inserted through the openings 104 of the yoke 92, and the clip 82has been rotated slightly along the direction of arrow A such that theupper surfaces of the tabs 120 snugly engage the inside surfaces of thesemi-annular portions 102. When the clip 82 is attached such that theflexing arms 114 are positioned approximately 90 degrees with respect tothe front end 94 of the yoke 92, the clip 82 can be removed from theyoke 92. In this embodiment, there are two positions in which theremoval can occur, and both of these positions are selected such thatthey would not occur when the mask is in normal use; otherwise the clips82 could be inadvertently detached from the yokes 92. FIGS. 10 f and 10g show the clip 82 in different rotational orientations with respect tothe yoke 92.

As seen in FIGS. 9 b and 10 b, the locking clip also has a plurality ofraised teeth 122 positioned in an arc about an axis of the retainingflange 118. The teeth 122 are constructed and arranged so as to engagethe teeth 108 on spring tab 106. Once the spring tab 106 has beendepressed to lower teeth 108, the locking clip 82 can be rotated to adesired position with respect to the yoke 92. The spring tab 106 canthen be released so that teeth 108 engage teeth 122 in the desiredposition (within a pitch of the teeth) and rotationally lock the lockingclip 82 with respect to the yoke 92. In accordance with one embodiment,the teeth 108 and 122 can be configured so that when a predeterminedtorque is applied to the locking clip 82, the teeth 122 willautomatically force the teeth 108 and spring tab 106 downwardly to allowrotation of the locking lip 82 until the torque is removed and the teeth108 re-engage the teeth 122. The locking clip 82 can thus berotationally adjusted with respect to the yoke 92 within an angle ofapproximately 50-100°, and preferably 75°, depending on the position ofengagement between teeth 108 and teeth 122. The angle of availablerotational adjustment can be altered as desired by altering the numberand positioning of teeth 108 and 122. The adjustment angle rangereflects the relative cushion positions required on the face. Rotationaladjustment with a toothed system as described above allows easyadjustment by the patient and allows a broad range of positions toaccommodate a wide range of patients' faces. For example, the patientmay adjust both locking clips 82 to have the same angle with respect tothe yokes 92. Alternatively, the patient may adjust the locking clips 82such that the locking clips 82 have different respective angles withrespect to the yokes 92. The toothed system allows the patient to easilyset and reproduce the desired angle for each locking clip 82. Forexample, the toothed system may allow relative movement between eachlocking clip and its respective yoke in, for example, five positions,which should accommodate most faces. Of course more or less than fivepositions could be used instead, depending on application. Moreover,once it is determined that a particular angle for each locking clip 82with respect to the yokes 92 is desired, the mask system may include anon-adjustable clip arrangement which fixes the rotational position ofthe locking clips 82 with respect to the yokes 92. The teeth are largeenough for the patient to easily determine the relative positions of thelocking clip with respect to the yokes.

Further, the spring tab 106 is configured and positioned such that thepatient cannot inadvertently depress the spring tab 106, e.g., byrolling over on the locking clip/yoke during sleeping, to cause thelocking clip 82 to move relative to the yoke 92. For example, as shownin FIGS. 10 e-10 g and FIG. 36 (a different embodiment), the lockingclip 82 extends further outwardly from the yoke 92 than the spring tab106. That is, the spring tab 106 is positioned lower than the outer edgeof the locking clip 82. Thus, the positioning of the locking clip 82with respect to the spring tab 106 prevents inadvertent actuation of thespring tab 106. Moreover, the spring tab 106 is connected to the yoke 92such that the yoke 92 can flex toward and away from the spring tab 106without disengaging the teeth 108 of the spring tab 106 from the teeth122 of the locking clip 82.

Alternative adjustment assemblies may be achieved by simple reversal ofsome or all of the sub-assemblies. For example, the central hub 119might be located on the yoke 92 while its reciprocal yoke central bore103 may be located on the locking clip 82. In a similar way, eachsub-assembly and its reciprocal may be reversed. Alternatively, the yoke92 and locking clip 82 may be adjustably connected by way of a screw orclamping mechanism, e.g., a part that may be separate from the yoke andclip, which can be used to selectively connect the yoke 92 and clip 82in a plurality of desired positions. In addition, the central bore 103can be shaped in any manner that allows detachment and attachmentbetween the yoke and the clip. Also, a system of replacement yokes thatwould allow a fixed angle with respect to the locking clip may be used.

The locking clip 82 also includes a central support tab 124 extendingoutward from the main body 112 between and generally parallel to springarms 114. The central support tab 124 is configured to have a close fitwith the central support slot 36, so that when the central support tab124 is inserted into the central support slot 36, little rotational,rocking or side to side movement is permitted between the locking clip82 and the locking clip receiver assembly 34. Central support tab 124 islonger than arms 114 to assist with alignment into the frame. Thelocking clip 82 also has an engagement face 125 that engages engagementface 35 (FIG. 5 c) when the locking clip 82 is inserted into the lockingclip receiver assembly 34 to provide additional support for the lockingclip 82. The latch hooks 116 and/or the central support tab 124 may havetapered widths and/or thicknesses to facilitate entry into slots 36, 38.Also, the latch hooks 116 and/or central support tab 124 may haverounded or contoured edges to facilitate entry into slots 36, 38.Further, the central support tab 124 may have a groove that engages aprotrusion provided in the central support slot 36 to facilitate entryof the central support tab 124 into the central support slot 36.Alternatively, the central support tab 124 may have a protrusion thatengages a groove provided in the central support slot 36.

When the locking clip 82 is inserted into the locking clip receiverassembly 34, the spring arms 114 are forced toward one another as thelatch hooks 116 are inserted into recesses 71 (FIG. 4) or ride up andover the locking flanges 39 (FIG. 7). Once the latch hooks 116 havecleared the locking flanges 39 or recesses 71, the spring arms 114 canspring outward, providing a locking engagement between the latch hooks116 and the locking flanges 39 and/or recesses 71. Sufficient clearanceis provided in locking slots 38 to allow the necessary movement of thelatch hooks 116 to clear the locking flanges 39.

In this manner, the respective left and right front strap assemblies,including front straps 84, yokes 92 and locking clips 82, can beattached to the frame 20 and the yokes 92 and front straps 84rotationally adjusted with respect to the frame 20 within an angle ofapproximately 50-100°, and preferably 75°.

In a preferred embodiment, the locking clip 82 is a unitary plasticpiece formed by injection molding. Examples of the plastic includenylon, acetal, polycarbonate, and polypropylene. In one embodiment, theretaining tabs 120 are formed during the molding process by moldprojections that leave bores 126 extending through the main body 112 ofthe locking clip 82, thereby separating under surfaces of the retainingtabs 120 from the main body 112.

Magnetic Interconnection

FIGS. 33-37 illustrate an alternative embodiment for removably couplingthe frame 420 and the headgear assembly 480. Specifically, the frame 420and the yokes 492 are structured such that the yokes 492 may bemagnetically coupled to the frame 420.

As shown in FIG. 33, the frame includes a main body 420 a and a pair ofside frame members 420 b. Similar to the embodiment of frame 20, themain body 420 a is structured to be removably coupled with the cushion40. Each side frame member 420 b includes a first connector portion 434for connecting to a second connector portion 435 provided by the yoke492 of the headgear assembly 480. In the illustrated embodiment, thefirst connector portion 434 includes a retaining structure 418 thatextends outwardly from the side frame member 420 b. The retainingstructure 418 is structured to retain a magnet 419. In one embodiment,the magnet 419 is constructed of Neodymium and has a cylindrical shapewith a diameter of 6.35 mm and a thickness of 6.35 mm. However, theretaining structure 418 may be structured to retain a magnet of anysuitable size and shape. Further, the outer edges of the side framemembers 420 b each include a plurality of raised teeth 422 positioned inan arc.

As shown in FIGS. 34 and 35, the yokes 492 of the headgear assembly 480each include structure that is similar to the yokes 92 of headgearassembly 80. Specifically, the yokes 492 each include the secondconnector portion 435 having a mounting flange 400 positioned on thefront end 494 thereof. The mounting flange 400 has an aperture orkeyhole 401 leading to a bore 403. Two semi-annular flanges 402 areseparated from each other by slots 404. A radial inner surface of thesemi-annular flanges 402 forms the central bore 403. The yoke 492 alsohas a spring tab 406 positioned rearward of the mounting flange 400 witha front portion of the spring tab 406 connected to the yoke 492 and arear portion separated from the yoke 492 by space 407 to be able to flexwith respect to the yoke 492 when pressure is applied to the spring tab406. The spring tab 406 preferably has a plurality of raised teeth 408positioned in an arc about an axis of the mounting flange 400. Thespring tab 406 also has a raised positioning member 410 at its free endto assist the user in locating, engaging and manipulating the spring tab406.

In contrast to the yoke 92, the yoke 492 includes a ferrous metal disk412 that is secured within the bore 403. In one embodiment, the metaldisk 412 is a steel washer with a diameter of 14 mm and a thickness of 1mm. However, the metal disk 412 may have any suitable size and shapethat can be mounted within the bore 403 of yoke 492. Further, a magnetof suitable size and shape may be used in place of the metal disk 412.

As shown in FIGS. 36 and 37, the first connector portion 434 of theframe 420 is engaged with the second connector portion 435 of the yoke492 such that the magnet 419 is magnetically coupled with the metal disk412. Specifically, the magnet 419 is axially inserted into the bore 403so that the magnet 419 is positioned adjacent to or engaged with themetal disk 412 which allows the magnetic attraction between the magnet419 and the metal disk 412 to axially retain the yoke 492 to the frame420. The strength of the magnetic attraction between the yokes 492 andthe frame 420 may be increased by replacing the metal disk 412 with amagnet, as discussed above. The retaining structure 418 is sized to havea close tolerance with the bore 403 so that the frame 420 and yoke 492are rotationally supported with one another.

Further, the teeth 422 on the frame 420 are constructed and arranged toengage the teeth 408 on the spring tab 406 when the frame 420 ismagnetically coupled with the yoke 492. Once the spring tab 406 has beendepressed to lower teeth 408, the yoke 492 can be rotated to a desiredposition with respect to the frame 420. The spring tab 406 can then bereleased so that teeth 408 engage teeth 422 in the desired position(within a pitch of the teeth) and rotationally lock the frame 420 withrespect to the yoke 492. In accordance with one embodiment, the teeth408 and 422 can be configured so that when a predetermined torque isapplied to the yoke 492, the teeth 422 will automatically force theteeth 408 and spring tab 406 downwardly to allow rotation of the yoke492 until the torque is removed and the teeth 408 re-engage the teeth422. The yoke 492 can thus be rotationally adjusted with respect to theframe 420 within an angle of approximately 50-100°, and preferably 75°,depending on the position of engagement between teeth 408 and teeth 422.

The magnet 419 in each side frame member 420 b may be oriented such thatan incorrect attachment (e.g., left side yoke 492 to right side framemember 420 b) is indicated by magnetic repulsion. Specifically, themagnet 419 on one side frame member 420 b is oriented so that it willonly magnetically couple with one of the yokes 492 and the magnet 419 onthe other side frame member 420 b is oriented so that it will onlymagnetically couple with the other of the yokes 492. Thus, sensoryindication of correct attachment of the frame 420 to the headgearassembly 480 is achieved by magnetic attraction of correctly pairedyokes 492 and side frame members 420 b. This construction ensures thatthe headgear assembly 480 and frame 420 are assembled correctly.Further, this construction enables the frame 420 to be easily coupledwith the headgear assembly 480, even in the dark, as the magnet 419 willautomatically locate itself in the correct position with respect to themetal disk 412. The headgear assembly 480 may be easily detached fromthe frame 420 by applying a suitable disengagement force that is greaterthan the attractive magnetic force between the magnet 419 and the metaldisk 412.

Alternatively, the first connector portion 434 on the frame 420 mayprovide a ferrous metal member and the second connector portion 435 onthe yoke 492 may provide a magnet.

Straps

Each front strap 84 includes a ladder-type buckle 128 attached to thetop strap 88 to connect the top strap 88 with a top strap 140 ofcross-over strap 138. See FIGS. 1-3 and 11. The buckle 128 can beattached to the top strap 88 with adhesives, stitching and/or otherknown manners, such as being manufactured integral with the strap. Inthe embodiment shown in FIG. 11, the buckle 128 includes a plurality ofbores 130 evenly spaced around an attachment tab 132 in the form of asquare to allow the buckle to be stitched to the top strap 88. Thebuckle further includes a crossbar 134 and a crossbar 136, around whichthe top strap 140 can be threaded, in a known manner, so that top strap140 wraps around crossbar 136 and a free end of top strap 140 ispositioned between crossbar 134 and a remainder of top strap 140. Thus,when tension is applied between the buckle 128 and top strap 140, thefree end of top strap is frictionally held between crossbar 134 and theremainder of top strap 140 so that the connection between buckle 128 andtop strap 140 is self holding under tension. A single cross bar bucklecan also be used if used in combination with a strap loop to hold thestrap in position. Of course, other connector members can be usedinstead of the buckle, as is known in the art.

As shown in FIG. 12, cross-over strap 138 has a generally elongatedshape in a relaxed state with two top straps 140 extending upward from across-strap 142 having ends 144. To place the cross-over strap 138 in aconfiguration for wearing, the two top straps 140 are threaded through across-over buckle 146, so that they are held in the cross-over position.See FIGS. 13 and 14. In this manner, the left top strap 140 ofcross-over strap 138 crosses over to connect with the buckle 128 ofright top strap 88 and the right top strap 140 of cross-over strap 138crosses over to connect with the buckle 128 of left top strap 88. Thiscrossing over of the respective straps helps maintain the headgearassembly 80 and nasal mask assembly 10 in a desired adjusted position onthe user. A strap loop 148 can be used to hold down free ends of therespective straps. See FIG. 15. In one form of the invention, the strapsare supplied oversized and then cut to length to suit the person.

Similarly to buckles 128 and top straps 88, buckles 150 (FIG. 1) can beattached to cross-strap ends 144 so that the cross-strap ends 144 can beconnected to the respective rear strap ends 90 of front straps 84.

Swivel Elbow Assembly

The swivel elbow assembly 60 of FIG. 6 a may be the same as is currentlyused in ResMed Limited's ULTRA MIRAGE® mask, which employs an internalC-clip member, as described above. The elbow assembly 60 of FIG. 6 a isintended to be used with a connector tube 300 (FIG. 23). The connectortube 300 is provided between the elbow assembly 60 and the gas deliverytube 310 (FIG. 26).

Alternatively, the swivel elbow assembly may be constructed inaccordance with FIGS. 1-4 and 16-22. Such a swivel elbow assembly 60 mayinclude a swivel elbow 160 and a vent cover 180. Swivel elbow 160 isrotationally connected to frame 20.

In another alternative form of the invention, a further swivel isconnected to the end of tube 310, as shown in FIG. 6 b.

As shown in FIGS. 16 a-19 c-2, swivel elbow 160 includes an intake port162 and an exhaust port 164. The air tube 310 (FIG. 26) is preferablydirectly connected to a stem 166 of swivel elbow 160 (without connectortube 300) to supply pressurized breathable air or gas from a pressurizedsupply through air tube 310, intake port 162 and into cushion 40 forbreathing by the patient.

The exhaust port 164 is separated from the intake port 162 using, forexample, a baffle 161 provided within the interior portion of the elbow160. See FIGS. 18 and 19 a-1. In the illustrated embodiment, the baffle161 has a generally planar configuration. However, the baffle 161 mayhave a curved configuration or any other suitable configuration forseparating the exhaust port 164 from the intake port 162. Theorientation of the intake and exhaust ports 162, 164 was selected suchthat the incoming gas, indicated by the directional arrow in the intakeport 162, less directly impacts the flow of gas washout along theexhaust port 164. Further, the gas entering the elbow 160 is less likelyto flow directly into the exhaust port 164 since the baffle 161 forcesthe incoming air to take a tortuous path, e.g., turn around about 180degrees, before being able to exit through the exhaust port 164.

The elbow 160 includes an end portion 169 that is adapted to engage theaperture 24 provided in the frame 20, to provide gas into the nasalcavity formed by the frame 20 and the cushion 40. The baffle 161terminates just inside the end portion 169 of the elbow. A flexiblequick release mechanism includes a collar 173 and an apron 170. Thecollar 173 includes a generally T-shaped member, as seen in FIG. 16 b,that surrounds the end portion 169 of the elbow 160. Preferably, the endportion 169 of the elbow 160 extends beyond the collar 173 to improvealignment when assembling into frame 20. The collar 173 is spaced awayfrom the end portion 169 in concentric relation so as to form areceiving space 183 between the collar 173 and the end portion 169, asshown in FIG. 18. The apron 170 is preferably formed as an integral partof the elbow 160, and is connected to the lower leg of the T-shapedcollar 173. Two grooves 167 are provided between the collar 173 and theapron 170. A portion 167 a of the groove 167 allows the lower leg of theT-shaped collar 173 to flex with respect to the apron 170. A portion 167b of the groove allows the cross portion of the T-shaped collar 173 toflex outwardly and inwardly with respect to the end portion 169 of theelbow 160.

FIGS. 19 a-1-19 c-2 show sequential views illustrating connectionbetween the elbow 160 and the frame 20. FIGS. 19 a-1-19 a-2 show a crosssection of the elbow 160 just before-connection with the mask frame 20.FIGS. 19 b-1-19 b-2 show the elbow 160 and frame 20 in the nearlyconnected condition, and FIGS. 19 c-1-19 c-2 show the elbow and frame inthe fully connected condition.

The frame 20 includes a flange 21 provided at a distal end of a wall 25defining the aperture 24. FIGS. 5 and 5 a show the flange 21, while theembodiment of FIG. 6 a does not show or include such a flange since adifferent elbow assembly 160 is employed. As the flange 21 is insertedwithin the space 183, it engages protrusions 181 formed in the insidesurface of the collar 173. In this embodiment, only two protrusions 181are provided. The protrusions 181 are ramped or inclined such thatengagement with the flange 21 causes outward flexure (FIG. 19 b-1-19b-2) of each end of the cross portion of the T-shaped collar 173, untilthe flange 21 aligns with and is received within the groove portion 167b (FIG. 19 c-1-19 c-2). In this state, with the elbow 160 secured to theframe 20, the collar 173 returns to its unflexed state. Portions of theflange 21 rest against lugs 165 provided within the space 183.

The engagement between the collar 173 and the flange 21 during thesnap-action connection of the elbow 160 and the frame 20 results in anaudible click or sound indication. This sound indication is advantageousto signal the user that the elbow 160 is securely attached to the frame20.

To release the elbow 160 from the frame 20, portions 185 on each side ofthe collar 173 are flexed towards one another in order to raise theprotrusions 181 radially outwardly to allow passage of the flange 21. Inthis manner, the elbow 160 can be quickly and easily removed from theframe 20 without accessing the interior portion of the nasal cavity, aswould be the case with an elbow connected using a C-clip (FIG. 6 b). Asshown in FIG. 16 b, a preferred form of the elbow 160 includes texturedprotrusions 185 to assist users to locate the release points. Thedistance between the opposed textured portions 185, i.e., the diameterof the collar 173, is approximately 35-45 mm, and preferably 40 mm.

The elbow 160 also is adapted to connect directly to the gas deliverytube 310 (FIG. 26) without the connector 300 shown in FIG. 23. (See FIG.1). FIG. 6 b shows the connector 300 between the elbow and the gasdelivery tube 310. Removal of the connector 300 is advantageous becausethe length of the effective lever arm of the combined elbow andconnector 300 (FIG. 6 b) may increase the possibility that unwantedlevels of torque are applied to the frame 20 or mask assembly 10relative to the patient's head/face. By eliminating the need to use theconnector 300, the effective length of the level arm can be reduced,which results in less torque being applied to the mask assembly whichresults in increased stability. With increased stability, patientcomfort is increased and compliance is increased.

In the connected state, the inside surface of the wall 25 of the frame20 sealingly engages the outside surface of the end portion 169 of theconduit as shown in FIG. 19 a-1-19 c-2. These surfaces engage oneanother for a distance of approximately 1-10 mm, preferably 6 mm, whichhelps to seal as well as to provide stability to the connection betweenthe elbow 160 and the frame 20. As seen in FIGS. 19 c-1-19 c-2, aportion of the wall 25 extends inside the mask 20 to further increasethe area of contact between the elbow 160 and the frame 20. In theconnected state, an end portion 173 a of the collar 173 is flush withthe outside surface 20 c of the frame 20, as shown in FIGS. 19 c-1-19c-2. The wall 25 includes a flange 25 a (FIG. 19 c-2) to form a stop forthe insertion of the end portions 169, and to permit a controlled leakbetween the elbow 160 and frame 20. In one embodiment, the leak betweenthe elbow 160 and frame 20 is minimal. In another embodiment, a seal isprovided between the elbow 160 and frame 20 to prevent a leak.

This system allows for the rapid and precise connection between theelbow 160 and the frame 20. It also allows for simple disassembly.Moreover, the elbow 160 is configured to allow the patient to attach anddetach the elbow 160 from the frame 20 with one hand. This isadvantageous when cleaning the mask or if the patient should choose tointerrupt treatment during a session, while intending to resumetreatment a short time later. The elbow assembly 60 and frame 20connection allows the patient to rapidly disconnect the elbow 160 fromthe blower's gas delivery tube while keeping the mask frame, cushion andheadgear in place on the patient's head during a momentary treatmentinterruption. The aperture 24 is large enough to lower impedance, tothereby enable the patient to breathe comfortably since a sufficientamount of gas can be accommodated by the aperture 24. Specifically, theaperture 24 has an area of at least 180 mm². In one embodiment, theaperture 24 has a diameter in the range of 20-30 mm, preferably 27 mm,and an area in the range of 200-600 mm², preferably in the range of500-600 mm². As illustrated, the aperture has a generally circularshape. However, the aperture may have a non-circular shape. Further, theframe may have a plurality of apertures therethrough with the elbowcoupled to the frame such that it surrounds the plurality of apertures.In this respect, a mask in accordance with an embodiment of theinvention differs from prior art mask arrangements which included quickrelease mechanisms with narrower apertures. Such narrower aperturedquick release mechanisms could lead to patient discomfort, for exampleanxiety or claustrophobia. Discomfort is exacerbated by increased CO₂re-breathing or increased flow impedance.

Vent Cover

Vent cover 180 includes a main body 182 having a lower bore 184, curvedportion 186 and top portion 188. See FIGS. 20-22. The main body 182 alsoincludes at least one vent 190, and in a preferred embodiment, aplurality of vents 190 extending from an interior of the vent cover toan exterior of the vent cover. Top portion 188 of vent cover 180includes flange or aperture 192 for engaging latch 168 of swivel joint160. In the illustrated embodiment, the vent cover 180 includes anaperture 192. The vent cover 180 is connected to the swivel joint 160 byplacing the stem 166 of the swivel joint 160 through lower bore 184 ofthe vent cover 180. The vent cover 180 is then moved toward the swiveljoint 160 until the latch 168 extends through the aperture 192, as shownin FIG. 1. This configuration allows for the vent cover 180 to remain inthe vicinity of the elbow assembly 160 and/or mask assembly 10, as it iscaptured by the elbow 160 or the gas delivery conduit. This isconvenient in that should the vent cover 180 become dislodged duringcleaning or by inadvertence, it will not drop and become lost, as it isretained by the mask assembly.

The curved portion 186 of the vent cover fits adjacent apron 170 of theswivel joint 160 to provide a generally air-tight seal between aninterior of the vent cover 180 and the swivel joint 160. In this manner,exhalation gases from an interior of the mask can flow through exhaustport 164 of swivel joint 160, through the interior of the vent cover 180and to the atmosphere through vents 190. FIG. 19 c-1 includes an arrow Bthat approximates the path exhaust gas follows when the vent cover is inposition. This arrangement has an additional advantage in that the ventdirection reduces or prevents irritation of a bed partner of the patientby gas flow from the mask. FIGS. 1-4 show the elbow 160 and vent cover180 in the connected position. A spacer 163 is provided to ensure thatthe vent cover 180 is spaced sufficiently away from the exterior surfaceof the elbow 160, which especially helps prevent the air gap fromcollapsing since the vent cover is preferably made of a resilientflexible material. Of course, the vent cover could be made of a plasticmember somewhat like the cover used in the Ultra Mirage™, if desired. Inaddition, this vent arrangement can be replaced or supplemented usingResMed's vent assembly disclosed, for example, in U.S. patentapplication Ser. No. 09/021,541, incorporated herein by reference in itsentirety.

FIGS. 18 b-18 e illustrate another embodiment of the swivel elbow,indicated as 360, that is adapted to be connected to the vent cover 380illustrated in FIGS. 22 b-22 e. As shown in FIGS. 18 b, 18 c, and 18 e,the swivel elbow 360 includes a flange 361 provided at a distal end of awall 362 surrounding the outlet of the exhaust port 364. FIGS. 18 d and18 e show the intake port 365, the exhaust port 364, and a baffle 369that separates the intake and outlet ports 365, 364. As illustrated inFIG. 18 e, the baffle 369 has a curved configuration. Specifically, thebaffle 369 curves generally downwardly as it extends from the inlet ofthe exhaust port 364 to the outlet of the exhaust port 369. However, thebaffle 369 may have a generally planar configuration similar to baffle161 shown in FIG. 19 a-1. Alternatively, the baffle may have any othersuitable configuration to separate the intake and outlet ports 365, 364.As shown in FIGS. 22 b-22 e, the vent cover 380 includes a main body 382having a lower bore 384, an intermediate portion 386 and top portion388. The main body 382 also includes a plurality of vent holes 390extending from an interior of the vent cover to an exterior of the ventcover. The top portion 388 of the vent cover 380 includes a collar 392for engaging the flange 361 of swivel elbow 360. The vent cover 380 isconnected to the swivel elbow 360 by placing the stem 366 of the swivelelbow 360 through lower bore 384 of the vent cover 380. The vent cover380 is then moved toward the swivel elbow 360 until the collar 392latches onto the flange 361 of the swivel elbow 360. The collar 392 isstretched to overcome the flange 361, and firmly grips the flange 361due to its resiliency and elasticity. In the illustrated embodiment, thecollar 392 has a generally circular shape so that stress (“hoop stress”)applied to the flange 361 and wall 362 is evenly distributed. Similar tothe embodiment of vent cover 180, this configuration allows for the ventcover 380 to remain connected on in the vicinity of the swivel elbow 360and/or mask assembly, as it is captured by the elbow 360 or the gasdelivery conduit. The vent cover can be considered “self-holding” inthat it can be held in place on the elbow to cover the exhaust passagewithout an additional securing mechanism. In addition, the vent cover isheld onto the elbow via the ring-shaped lower bore 184 as the patientstretches the collar 392 over the flange 361, which minimizes thechances for losing the vent cover if the first assembly attempt is notsuccessful.

FIG. 22 f shows the swivel elbow 360 and vent cover 380 in the connectedposition. As shown in FIGS. 18 c and 18 e, the swivel elbow 360 includesa wall 363 that ensures that the vent cover 380 is spaced sufficientlyaway from the exterior surface of the swivel elbow 360, which especiallyhelps prevent the air gap from collapsing since the vent cover 380 ispreferably made of a resilient flexible material. The vent cover 380includes a recess 389 (FIG. 22 c) on an inner surface of the top portion388 that engages the wall 363.

Mask Cushion

The cushion is designed to rest on the face and apply pressure aroundits perimeter while minimizing and/or avoiding contact with pressuresensitive regions on the face. Some parts of the face require specialattention to achieve a balance of pressure and seal. It is alsodesirable to provide a low profile mask to improve patient comfort levelby improving stability, and to reduce the forces which may tend to pivotthe mask relative to the patient's face. Properties are listed belowwith the measures taken to create a successful design.

The cushion has a face-contacting side and a non face-contacting sidewith a wall therebetween. The non-face contacting side of the cushionengages with the mask frame. In one form of the invention, the shape ofthe cushion on its face-contacting side, as per the view shown in FIG.24 c, is generally trapezoidal. In this aspect, the shape of the cushionon the face contrasts with prior art cushions having a generallytriangular shape. An advantage of this trapezoidal shape is that itassists sealing at a point lower down the nose without impeding flowthrough the patient's or user's nasal vents (that is, in the region ofthe lateral nasal cartilage and just below the nasal bone on either sideof the nose). Thus, the cushion is positioned on a lower portion of thenasal bridge region of the patient. Moreover, the cushion is configuredand positioned such that contact pressure of the cushion on the nasalvents is minimized or eliminated. The shape of the cushion may bealtered, e.g., a triangular or other non-trapezoidal shape could beused, keeping in mind that localized pressure points on the lower nasalbridge region and occlusion of the nasal vents should be avoided. Someprior art mask cushions push on the nasal vents which can increase theimpedance of the nasal vents to airflow. In a preferred form of thecushion, both the face-contacting and non face-contacting sides of thecushion have the same general trapezoidal shape.

In one form of the invention, a combination of support structure andsealing structure is provided in the region of the face contacting sideof the cushion. The support and sealing structures may be provided aspart of the cushion, or alternatively using separate components. Wherethe support and sealing structures are provided as part of the cushion,the cushion may have a single-walled, double-walled or triple- or morewalled construction. In a preferred form of cushion, the sealingstructure is provided by a thin membrane, whereas the support structureis provided by a thicker frame.

The center and sides of the nasal bridge are particularly sensitive tocontact pressure. Thus, it is important that the cushion seals aslightly as possible in this area. Instability of the cushion may causean increased pressure in the nasal bridge region and thus presents anextra challenge in this area. The supporting element (e.g., frame 200shown in FIG. 24 a) can be designed to totally avoid contact with theadjacent portion of the overlying face-contracting element (e.g.,membrane 205 shown in FIG. 24 a), thereby allowing the membrane 205alone to seal. While localized points of contact pressure should beavoided in the nasal bridge region, especially at the sensitive apexthereof that contacts the lower nasal bridge region, the seal must bemaintained. The lower nasal bridge region is positioned generally wherethe bony region of the nasal bridge transitions to a portion of the nosecontaining more cartilage. In addition, the forces that are applied tothe face should be substantially evenly distributed around the entireperimeter of the cushion 40. An aspect of the invention is that thefacial contact pressure is controllably distributed around the face. Ofcourse, the forces applied to the lower nasal bridge region can bespread out along a relatively wider section of the membrane 205, toavoid the localized forces, while the forces in the lip and cheekregions can be slightly more localized, e.g., spread out over lessdistance in the width direction, since forces can be more comfortablyaccommodated in the lip and, particularly, in the cheek regions.Moreover, the contact area or width between the membrane and the face inthe lower nasal bridge region may be greater than the contact area orwidth between the membrane and the lip and cheek regions, whilemaintaining a relatively constant overall force distribution around theface of the patient, which improves comfort. Using this arrangement, thepatient perceives that the pressure is evenly distributed over thecontact region, even though the actual force over the contact region maynot be evenly distributed.

Another advantage is that the angle of the cushion with respect to thepatient can change without adversely affecting sealing efficiency. Forexample, the cushion may contact different patients at different anglesbased on the shape of the patient's face, and the angle of the cushioncan move with respect to the face during movement when the patient isasleep.

The sealing element (e.g., membrane 205) incorporates a large effectiverolled over section (large radius) to allow some degree of movement orrotation of the mask relative to the patient's face and prevents themembrane distal edge from irritating the patient's face and/or nose. Thesealing element (e.g., membrane) snugly seals against the nose byconforming around a lower portion of the nasal bridge at sides of thenose. A compromise must be reached between a secure seal and membranetightness/stretching across the nose. The membrane cutout can be notchedto enable maximum stretch distance without edge tightness. Stretch canalso be achieved by materials, for example softer material and orthinner materials, for example, elastomer, silicone, polyurethane,thermoplastic elastomers, foamed elastomers and/or composites.

The sealing element (e.g., membrane) is preferably elastomeric having athickness in the range of 0.1 and 2.0 mm, preferably 0.35 mm, to allowthe membrane to stretch readily over the lower portion of the nasalbridge. The stretch of the membrane may be varied in different regionsby varying its thickness, adding stiffening structure such as ribs, orusing composites.

Facial wrinkling is most pronounced at the facial or nasal creasebetween the sides of the nose (also known as the naso labial sulcus) andthe cheek and presents a challenge in effective sealing. The underlyingcushion (e.g., frame 200 shown in FIG. 24 a) sits as close to the sidesof the nose as possible. In this way it seals in the flattest areapossible. The curved area designed to sit in the facial crease shouldhave as small a radius as is practical. The membrane 205 extendsinwardly and/or downwardly further than the edge of the cushion (e.g.rim 225) to allow rolling around the outer edge at the sides of thenose. This lessens the likelihood of irritation arising from rough edgesand prevents the inner cushion rim 225 from being a source of irritationagainst the patient's face and/or nose.

Excess pressure across the top lip can be caused by both cushion designand by the vertical rotation of the mask under its own weight, or byundesirable force applied to the mask, for example, due to tubing dragor the weight of components attached to the mask. The design of theheadgear, as described above, can help reduce the possibility of addingunwanted pressure to the lip region due to vertical rotation of the maskunder its own weight. The lip region 42 may include a notch toaccommodate the bottom of the septum of the patient, to enhance sealingand comfort, as shown in FIG. 24 g. The septum notch 264 would beprovided in region 265, as shown in FIG. 24 c. FIGS. 24 a and 24 b showfront and rear views of the cushion 40. In an alternative embodiment, aseptum notch may also be provided on the underlying frame.

The cushion 40 preferably has a generally trapezoidal shape in thisembodiment. However, the cushion 40 may have a non-trapezoidal shapesuch as a triangular shape. The cushion 40 includes a pair of cheekregions 41 to provide a seal in the crease between the cheeks and thesides of the nose, a lip region 42 provided to provide a seal below thenose and above the upper lip of the patient, and a nasal bridge region43. The nasal bridge region 43 spans across the lower portion of thebridge and sloping sides of the bridge that intersect with the nasalcrease formed between the cheeks and the sides of the nose. Thetransition between the lip region 42 and each cheek region 41 is wherethe cushion 40 begins to turn around the bottom of the nose towards theside of the nose. The transition between the nasal bridge region 43 andeach cheek region 41 is where each cheek region 41 diverges upwardlytowards the bridge of the nose. In other words, the nasal bridge region43 starts where the cheek region begins to angle upwardly. See FIG. 24d.

The nasal bridge region 43 is designed to contact the patient's nose,for example, as shown in FIG. 1, where it can be seen that the lowerportion of the bridge is selected for contact. Note that FIG. 1 showsthe cushion 40 spaced away from the frame. However, pictures in AppendixC of incorporated U.S. Provisional Application of Moore et al., Ser. No.60/402,509, show the nasal mask assembly attached to two model noses (A& B), described further below. More specifically, the nose includesrelatively bony sections at the upper portion of the bridge, andflexible cartilage at the tip of the nose. Reference may be had toGray's Anatomy, Thirty-Eighth Edition (1995), FIGS. 6.133A, B, 6.135Aand 11.3A, B, incorporated herein by reference for drawings showingthese regions. It is desirable to avoid localized pressure points alongthe bony region of the nose, to increase comfort to the patient.Conversely, it is desirable to avoid mask contact with only thecartilage portion of the nose, because its flexibility may allow toomuch unwanted movement of the cushion in use, may occlude the nasalpassages of the patient, and may not provide a stable fit. In addition,positioning on the tip of the nose may increase the distance between thecenter of gravity of the mask assembly of the face of the patient—anundesirable consequence.

Accordingly, the optimal region of sealing engagement between thecushion and the bridge is somewhere between the uppermost bony regionand the lower cartilage region of the nose. Optimally, the region ofcontact is just above the cartilage on the bone. Generally, the cushioncan sit on the bone along the center of the nose, but it needs to avoidareas of cartilage on the sides of the nose. The nasal length and otherappropriate dimensions can be measured from the base of the nose and thetransition, or it can be obtained from statistical information on humananatomy. Samples of typical dimensions which are considered include oneor more of those found in FIGS. 30 and 31. However, the cushion may notcontact the patient in the lower nasal bridge region (positionedgenerally where the bony region of the nasal bridge transitions to aportion of the nose containing more cartilage) in all cases due todifferences in the facial contour for each individual patient.

The cushion 40 is designed to accommodate most of the patient population(e.g., 80% of the patient population) in one or more sizes, preferablyone to three sizes. The distance between the base of the nose and thetop of the bridge is longer than the distance between the base of thenose and the transition between bone and cartilage. The cushion 40 canbe made compact and/or lightweight since it need not accommodate theentire length of the nose. This frees designers to optimize or improveother areas of the cushion 40 and increases the patient's field of viewwhile wearing the mask. Certain facial dimensions have been identifiedfor optimal mask design to maximize the portion of the population thatcan be accommodated. In one embodiment, a series of color coded cushionsis used. The cushion may be color coded for type or size, for example.

FIGS. 24 a-g show additional views of the cushion 40. As shown in FIG.24 e, the cushion 40 includes a frame 200 and a membrane 205 attached tothe frame. The frame 200 and membrane 205 are formed, for example, in aone-shot injection molding process as is known in the art, using, e.g.,silicone such as SILASTIC™ with 40 durometer hardness. Of course, theframe 20 and the membrane 205 can be formed from two different piecesthat are connected together and/or to the frame 20. The frame 200 has anedge 210, which may be attached to the channel 26 of the frame 20, asdescribed in relation to FIGS. 27 a-29 d. The edge 210 of the frame 200may be attached to the frame 200 with clips, straps, friction orinterference, direct molding to the frame, adhesives and/or a tongue andgroove arrangement, as is known in the art. The edge 210 and a centralportion or sidewall 215 above the edge 210 has a thickness which is ableto withstand buckling forces which can be applied when the cushion 40 isplaced in engagement with the channel 26 of the frame. In one form thecentral portion 215 has a thickness of 2-10 mm, preferably 5 mm. Thecentral portion 215 extends from the edge 210 to a transition line 220where the thin membrane 205 joins with the underlying frame 200, betweenthe frame 200 and the membrane 205. In the preferred embodiment, theheight of the central portion 215 of the frame 200 is most in the cheekregions 41 and less in the lip and nasal bridge regions 42, 43.

Beyond the transition line 220, the frame 200 includes a rim 225. In apreferred form, the rim 225 has a curved shape that curves inwardly intothe nasal cavity of the cushion 40. In an alternative form, the rim maybe provided by a solid piece having a generally round cross-section. Themembrane 205 forms a seal forming portion 270 (FIG. 24 e) which contactsthe patient in the lower nasal bridge region, cheek and lip regions41-43. The rim 225 has a thickness that is preferably less than thecentral portion 215 of the frame 200, but preferably greater than themembrane 205. For example, the membrane 205 has a thickness in the rangeof between about 0.1-2.0 mm, and preferably 0.35 mm, while the rim 225has a thickness of between about 0.5 and 2.0 mm, and preferably 1.35 mm.While it is preferable that the membrane 205 be thinner than the rim225, they could have the same thicknesses. The membrane 205 completelycovers and surrounds the rim 225 of the frame 200, as shown in FIG. 25.The inside surface of the membrane 205 is spaced from the outsidesurface of the rim 225 so as to form a compliant seal with the patient.By compliant seal, it is meant that the membrane 205 can accommodatesmall variations in the shape of a patient's facial/nasal featureswithout undue force, and can account for small movement of the maskrelative to the patient during use, while maintaining an effective seal.The membrane 205 is preferably spaced away from the rim 225 at least inthe nasal bridge region 43, especially at a region 43 a near the apex ofthe nasal bridge region 43 (FIG. 24 c). This is because that area of thepatient is most sensitive to localized contact pressure. Stateddifferently, the membrane 205 is preferably the only portion of thecushion 40 that contacts the patient to apply a sealing force to thepatient in the lower portion of the nasal bridge region 43. The membrane205 can better evenly distribute the force across the entire bridge ofthe nose, applying a lighter pressure, thereby improving comfort. Ofcourse, the sealing force applied to the transition between the bonyregion and the cartilage region of the nose is not so great as topartially or wholly close the nasal vents.

The rim 225 in the nasal bridge region, especially at the apex thereof,is spaced a sufficient distance away from the membrane 205 to avoidlocalized pressure points or regions on the lower bridge region of thenose. Moreover, the rim 225 should be inwardly curved to evenlydistribute forces which may cause the membrane 205 to contact the rim225. Such forces may be the result of over tightening the headgear 80 orinstability due to patient movement. The cushion 40 is designed to avoidcontact between the rim 25 and the membrane 205 in the lower nasalbridge region even if the headgear 80 is over-tightened. In that event,the rim 225 in the lower nasal bridge region (at least at the apex 43 a)can be eliminated to save material and weight, so long as the structuralintegrity of the cushion 40 is not compromised. Moreover, the rim 225need not be curved along the entire perimeter thereof, especially thoseportions that are designed not to contact the membrane 205 in use.

Spacing between the membrane 205 and the rim 225 in the cheek and lipregions 41, 42 is not necessary, but will add comfort and enable thecushion 40 to fit a wider range of patients due to the compliantmembrane 205.

A cushion in accordance with the invention provides improved stabilityover prior art cushions. The footprint, or contact area has beenmaximized, particularly along the sides of the nose. The side contactregions of the cushion have been maximized. This provides two furtheradvantages. First, since the side walls of a cushion in accordance withthe invention are longer than some prior art cushions, it is possible todesign a mask which seals above the nasal vents but below the upperportion of the nasal bridge. Second, by distributing the contactpressure over a larger footprint, or contact area, stability of the maskassembly is improved. As such, the cushion 40 is much less likely torotate in the vertical plane, as compared to prior art masks which tendto rotate about an axis substantially over the lip region.

FIGS. 25 d-25 i show cross sections of the cushion 40. As shown in FIG.25 d, the distance between the rim and the membrane in the nasal bridgeregion 43 is in the range of about 5-14 mm, preferably 9 mm. As shown inFIG. 25 e, the distance between the rim and the membrane is in the rangeof about 7-16 mm, preferably 11 mm. As shown in FIGS. 25 f, 25 g, 25 h,and FIG. 25 d and 25 i in the lip region, the distance is in the rangeof about 1-6 mm, preferably 4 mm.

FIGS. 25 d-25 i also show various other dimensions in one preferredembodiment, such as the radii of curvature, the angles at which themembrane extends, etc. For example, at the apex of the nasal bridgeregion, in FIG. 25 d, the radius of curvature of the membrane is in therange of about 5-14 mm, preferably 9 mm, with an angle of about 70-90degrees, preferably 80 degrees. As shown in FIG. 25 e, the radius ofcurvature is within the range of about 4-10 mm, preferably 7 mm, with anangle of about 50-70 degrees, preferably 60 degrees. Generally, thespacing in the nasal bridge region 43 should be more than the spacing inthe cheek and lip regions 41, 42. Of course, a cushion with a combinedmembrane and rim could be provided as well, e.g., a one layer structure.Conversely, the support function of the rim 225 could be accomplishedusing two or more support rims to support the membrane 205, or two ormore membranes could be provided over a single rim. In anotheralternative, the support function of the rim and the sealing function ofthe membrane can be split into two different members, which may be madeof different materials.

FIG. 24 e shows that the membrane 205 includes a preformed, contourednotch 255 in the nasal bridge region 43 to match generally the typicalcontours of the lower portion of the bridge region of the patient. Theframe 200 includes a notch 260 which is co-located in relation to thenotch 255. The shape of the notch 255 is generally U-shaped, while theshape of the notch 260 is generally wider than the notch 255, and thenotch 260 is generally U-shaped. As shown in FIG. 24 f, the notch 255has a depth d₁ in the range of 12-27 mm.

As seen in FIGS. 24 a-c, an inner edge 230 of the membrane 205 definesan aperture 235 of the membrane 205. In this preferred form, the shapeof the aperture 235 is generally trapezoidal and has a base width w ofabout 31-45 mm, sides with a length s of 20-22 mm, and a top portion t,generally parallel to the base portion with a length of about 5-10 mm.See FIG. 24 c. The included angle α is in the range of 45°-55°, andpreferably 50°. The height h between the base portion and the topportion of the membrane 205 is in the range of 19-22 mm. Further, theoverall height h_(o) of the cushion 40 is in the range of 45-55 mm,preferably 50-51 mm and the overall width w_(o) of the cushion 40 is inthe range of 65-75 mm, preferably 69-71 mm. Also, as shown in FIG. 24 f,the dimension d₂ of the cushion is in the range of 29-31 mm and thedimension d₃ of the cushion is in the range of 41-43 mm. In oneembodiment of a cushion 40 that has a “standard size”, the membrane 205of the cushion 40 has a width w in the range of 31-34 mm preferably 33mm, a height h in the range of 19-28 mm, preferably 22 mm, and the notch255 has a depth d₁ in the range of 19-23 mm, preferably 21.5 mm. Inanother embodiment of a cushion 40 that has a “deep” size, the membrane205 of the cushion 40 has a width w in the range of 31-34 mm, preferably33 mm, a height h in the range of 19-28 mm, preferably 22 mm, and thenotch 255 has a depth d₁ in the range of 22-27 mm, preferably 24 mm. Inyet another embodiment of a cushion 40 that is wider and/or shallower indepth (“wide/shallow”), the membrane 205 of the cushion 40 has a width win the range of 35-45 mm, preferably 41 mm, a height h in the range of19-28 mm, preferably 22 mm, and the notch 255 has a depth d₁ in therange of 12-20 mm, preferably 16 mm. It is to be understood that thesedimensions refer to a particular embodiment of the invention, and adifferently sized mask (for example, a “small” size versus a “large”size) while having the same shape would have different dimensions andnevertheless be within the scope of the invention. Further, while the“standard” size cushion, “deep” size cushion, and “wide/shallow” sizecushion may be provided individually, these cushions may be providedtogether as a set of cushions. This set of three cushions provides agood fit in a wide range of patients without having an excessiveinventory.

The sides s of the membrane 205 adjacent the aperture 235 include acurved portion 250 (FIG. 24 c) between the nasal bridge 43 and lipregions 41. The curved portion 250 appears as a bulged portion curvinginwardly toward the aperture 235. In FIG. 24 f, the curved portion 250appears outwardly bulged in relation to the adjacent surfaces. FIG. 24 ealso shows the depth of the notch 255 provided in the membrane 205 inthe nasal bridge region, as seen from the top view. FIG. 24 d providesyet another view of the curved portion 250, and the shape of themembrane 205 in relation to the underlying shape of the rim 225. Thecurved portion 250 helps provide a good seal along the sides of the nosein the crevice where the cheek meets the nose. For example, as seen inFIG. 24 c, the portion 250 is spaced away from the edge of the rim 225so that more allowance for sealing in the crease and along the sides ofthe nose is provided. The edge 240 of the rim 225 and the edge 230 ofthe membrane 205 in the cheek region 41 begin diverge away from oneanother at an angle, as seen in FIG. 24 c. The spacing between the edges230, 240 of the membrane 205 and the rim 225 are smallest in the lipregion 42, and gradually increases in the cheek regions 41, and is mostin the curved portion 250 and nasal bridge region 43, as shown in FIGS.25 e-25 i.

The inner edge 240 of the rim 225 which defines an aperture 245 is shownin FIG. 24 b. The base width W of the aperture 245 is in the range of38-45 mm. The length of each side S is in the range of 20-23 mm. Thelength of the top portion T is in the range of 15-20 mm. The height Hbetween the base portion and the top portion of the is in the range of32-36 mm. These dimensions, and all other dimensions provided herein,are preferred dimensions and could be changed depending on theparticular application. While the shape of the aperture can also becharacterized as generally trapezoidal, the trapezoid is not in the sameproportions to the trapezoidal shape of the aperture 235 of the membrane205. The aperture 235 is smaller than the aperture 245.

Further, the apertures 235 and 245 may have a triangular shape or othernon-trapezoidal shape. Further, the overall shape of the cushion may betriangular or non-trapezoidal. The shapes of the apertures 235 and 245and cushion may be similar to one another or may be different, e.g., theaperture 235 has a trapezoidal shape and the aperture 245 has atriangular shape.

The width of the membrane 205 as measured from the transition line 220to the edge of the membrane 205 is greatest in the curved portion 250and nasal bridge region 43, less in the cheek regions 41, and the leastin the lip region 42. The membrane 205 generally extends upwardly awayfrom the transition line 220 in the nasal bridge, cheek and lip regions41-43. In the nasal bridge region 43, the membrane 205 curves inwardlyalong a generally constant radius to terminate at the edge 230. In thecheek regions 41, the membrane 205 curves around the rim 225 and theninwardly away from the rim 225 at an angle generally toward the oppositebottom position of the frame 200. In the lip region 41, the rim 225 andthe membrane have substantially the same shape. See FIGS. 25 d-25 i.

Mask Frame and Cushion Connection System

The mask of the present invention may be fabricated in a manner wherethe mask frame and mask cushion are permanently attached to each other.For example, the mask frame and cushion may be formed from the samematerial in one piece where the elbow is attached as a separate piece.Alternatively, the mask frame and cushion may be formed as two pieces ofthe same or different material where the cushion and mask shell areattached in a permanent manner. The permanent attachment may be achievedthrough co-molding, adhesives, the use of clips or other mechanicalmeans.

Alternatively, the mask frame and cushion may be attached by way of amethod that allows for it to be detached and then re-attached repeatedlythrough the useful life of the mask, as will be described below. Thisallows for disassembly for effective cleaning and maintenance or evenallows replacement if a part is worn out.

The mask shell and cushion connection system of the present inventionallows for the manufacture of a combination mask frame and cushion thatallows for the independent determination of forces for engagement of thecushion and disengagement of the cushion from the frame. Because of thisability, it is possible to fabricate a mask connection system where theengagement force is equal to the disengagement force, or where theengagement force is less than the disengagement force, or where theengagement force is greater than the disengagement force.

The connection system may be designed to achieve a disengagement forcethat is less than or greater than the force asserted upon the masksystem at maximum treatment pressure.

Preferably the disengagement force (i.e. the force that will detach thecushion from the mask frame) will be greater than the force that wouldbe asserted against the mask shell and cushion combination when themaximum treatment pressure is achieved in the mask chamber. By settingthis lower limit for the disengagement force by reference to that forceasserted against the frame and cushion combination, the likelihood of amask disengaging during the application of treatment pressure isreduced.

While the minimum disengagement force is preferably determined byreference to the force asserted by treatment pressure, the maximumdisengagement force ought to be no greater than the force that iscapable of being comfortably exerted by a user when manually disengagingthe mask to prevent inadvertent release and annoyance to the user.Preferably, the displacement force will be no greater than the forcethat may be comfortably exerted by a user.

The engagement force for the cushion (that is the force required tocorrectly connect the cushion to the mask shell) may be predeterminedand achieved by adoption of the sealing and retaining mechanisms of thepresent invention.

Preferably the engagement force will be no greater than the force thatmay be comfortably exerted by the user. As the present invention hasapplication in a mass-produced product range, preferably the maximumengagement force will be no greater than the force that may be exertedby the target user population. In a clinical setting that targetpopulation may be the clinical staff who will be fitting and applyingthe mask to patients. In a non-clinical setting that target populationmay be the population of end users. Preferably the target engagementforce would be determined by considering the preferred engagement forcethat may be exerted by the target population when manipulating the maskshell and cushion in a conventional manner. Of course, these principlesalso apply to the disengagement force as well.

In one embodiment of the nasal mask assembly 10, an improved mechanismis used for engaging, i.e., retaining and sealing, the cushion 40 to theframe 20. See FIGS. 27 a-29 d. With the retaining and sealing mechanism,the cushion 40 can be fitted to the mask frame 20 in one movement thatretains the cushion 40 and forms a secure seal with the frame 20. Outerwall 30 of channel 26 on frame 20 is provided with a plurality ofundercuts 33 spaced around the outer wall 30. The undercuts 33 can passpartially or completely through the outer wall 30. A slight taper can beprovided to the interior surfaces of inner wall 28 and outer wall 30 toease assembly of the cushion 40 to the frame 20. The cushion 40 includesa side wall 215. As shown in FIG. 25 d, the side wall 215 has a width bof about 5 mm. The side wall 215 includes a plurality of retention lips44, spaced around the side wall 215 to align with the undercuts 33. Eachretention lip 44 includes a leading edge 45, tapered to ease insertionof the cushion 40 into the channel 26, and a retention surface 431,shaped to catch the undercut 33 and prevent separation of the cushion 40from the frame 20 until a predetermined separation force is appliedbetween the cushion 40 and the frame 20. Preferably the predeterminedseparation force is designed to be greater than the force to insert thecushion 40 into the channel 26. Distally positioned on the side wall 215are upper and lower sealing lips 46 and 47 extending outward from theside wall 215 and running around a periphery of the side wall 42.Opposite the sealing lips 46 and 47 are upper and lower sealing lips 49and 48 extending inward from the side wall 215 and running around aninner periphery of the side wall 215. Opposite the retention lips 44,the inner surface of the side wall 215 has a relieved portion 50 thuscreating a space between the wall of the cushion and the channelallowing the wall of the cushion 40 to distort into the relieved portion50, as shown in FIGS. 27 b and 27 e, making insertion of the cushion 40easier. The relieved portion 50 can be positioned just opposite eachretention lip 44 or the relieved portion 50 can extend all the wayaround an inner periphery of the side wall 215.

Assembly of the cushion 40 to the frame 20 according to one embodimentof the invention will now be described. The cushion 40 is firstgenerally aligned with the channel 26. See FIG. 27 a. The inner wall 28is slightly higher than the outer wall 30 to assist in aligning thecushion 40 with respect to the channel 26 before the cushion 40 entersthe channel 26. The cushion 40 is then moved into the channel 26. SeeFIG. 27 b. The leading edge 45 of each retention lip 44 will engage atop portion of the outer wall 30 and begin to deform. The relievedportion 50 of the side wall 215 allows this deformation to happenwithout greatly increasing the force necessary to insert the cushion 40into the frame 20. The sealing lips 46-49 have contacted the respectivesurfaces of the inner and outer walls 28 and 30 of channel 26. Thecushion 40 is further inserted into the channel 26 until it bottomsagainst the channel floor 32. See FIG. 27 c. The sealing lips 46-49 arein full contact with the inner and outer walls 28 and 30. Each retentionlip 44 has entered the respective undercut 33 but there is stilldeformation of the side wall 215, accommodated by the relieved portion50. The cushion 40 is then slightly withdrawn as compression of theelastomer (Silastic™) relaxes from the channel 26, seating the retentionsurface 431 of each retention lip 44 against the respective undercut 33,with the sealing lips 46-49 in continuous sealing position around theinner and outer walls 28 and 30. See FIG. 27 d. This withdrawal andseating provides a tactile signal to the user that the cushion 40 isproperly seated in the channel 26. If the undercuts 33 are made visibleto the user in this position, a visual indicator of seating is alsoprovided. Deformation of the side wall 215 has generally been removed atthis point and the relieved portion 50 returned to its relaxedconfiguration. Further withdrawal of the cushion 40 from the channel 26,to disassemble the cushion 40 from the frame 20 will deform theretention lip 44 downward. See FIG. 27 e. This deformation of the sidewall 215 will again be accommodated by the relieved portion 50. Theshape of retention lip 44 results in the preferred more secure removalforce compared to assembly force by the user.

Furthermore, where the cushion sealing lips or retention lip or both aremade of a material that expands over time such as with some chemicalcleaning exposure (i.e. increases in size in at least one dimension)such a material being silicone, the extra size or volume resulting fromspread of material may be accommodated within the channel 26, say by thesealing lips or retention lip flexing. This aspect of the invention hasadvantages over the prior art in that the spread of cushion materialought not compromise the seal of the mask shell and cushion, therebyprolonging the useful life of the component made of the expandablematerial.

The prior art typically requires the cushion material to achieve a snugfit with the frame so as to prevent leakage of gas from the mask chambervia one or more paths between the frame and cushion. In addition somemasks utilized an interior or exterior cushion clip to sandwich thecushion between the clip and the frame. Such cushion clips are found inRespironics' ComfortSelect mask, and in ResMed's Ultra Mirage™ mask,which is described in U.S. Pat. No. 6,412,487, incorporated herein byreference.

With the prior art, should the cushion be made of a material thatspreads with time, there is a tendency for the material to increase inat least one plane to the extent that it becomes difficult to fit ordisengage from the mask frame channel, or to otherwise make use of acushion clip. Also, the seal to prevent gas escaping from the maskchamber is compromised due to gaps appearing between the cushion sealportion and the mask frame channel. The prior art limitations have beendescribed with reference to a mask which has the sealing channel locatedin the frame and the sealing edge located on the cushion. However,similar limitations will apply where the location of these features arereversed, that is to say where the sealing channel is located on thecushion and the sealing edge is located on the mask shell as well aswhere the interface between the cushion and mask shell surface are inthe form of flat surfaces.

As treatment pressure within the mask chamber is not being achievedduring mask assembly, the selection of engagement pressure is notnecessarily determined by reference to the force exerted duringtreatment. Rather, it is possible to fabricate the connection system ofthe present invention so as to achieve an engagement force that is lessthan the disengagement force—such a configuration, where the engagementforce is less than the disengagement force is consistent with data thatany given human population is typically capable of exerting a pullingforce (i.e. where one or two hands move away from a starting point whilegripping an object) than they are capable of exerting a pushing force(i.e. where one or two hands move towards a fixed point while grippingan object).

The embodiment described above can maintain the relationship of adisengagement force being greater than an engagement forcenotwithstanding that a dimension of a component may change overtime—such as is the case where the cushion is made of a material thatexpands over time such as is the case with silicone.

The embodiments of the present invention also overcome the prior artlimitation of loss of friction fit where at least one component such asthe cushion is made of a material that tends to lose its frictionalquality over time, such as with silicone which material tends to become‘greasy’ due to chemical change and its own absorption of environmentalpollutants, such as the patient's skin oil. Accordingly, the presentinvention addresses the prior art problem of a loss of engagement effectbetween the frame and cushion over time notwithstanding the loss of thefriction between them.

While the present invention teaches away from the need for strap, clipor other additional retaining devices, such devices may be included inthe fabrication so as to add further security of engagement betweenframe and cushion or to otherwise reduce the design tolerances requiredto achieve a disengagement force that is consistent with the upper limitconsidered appropriate for the target population while maintainingengagement during the maximum treatment pressure.

The cushion 40 includes at least one sealing lip which functions toprevent escape of gas from the mask chamber via the interface betweenframe and cushion. Preferably there are provided at least two seal lipseach having relatively small contact points with the frame channel 26 asshall be described so as to minimize the friction occurring duringassembly and disassembly of the cushion with the frame withoutcompromising the seal.

If one seal lip were used, then its configuration to achieve adequatesealing may require it to assert greater friction once in position thanwould be the case where there were adopted two or more seal lips of thesame material.

By control of this source of friction, it is possible to influence theengagement and disengagement forces, i.e., the forces required to engageand disengage the cushion and frame. The preferred aim being to havethose forces remain with defined limits for the expected useful life ofthe cushion.

The relieved portion 50 of the side wall also accommodates deformationof the side wall 215 upon assembly and disassembly of the cushion 40 andframe 20, thereby reducing the force necessary for assembly/disassembly.This is especially important where the cushion 40 is made from a pliablebut generally slightly compressible material, such as silicone.Alternatively, the inner wall 28 can be provided with an undercut 29opposite each undercut 33 to accommodate deformation of the side wall215. See FIG. 28. The undercut 29 (and/or relieved portion 50) can besized and configured as desired to best accommodate the expected sidewall deformation. Different combinations of the sealing lips 46-49 canalternatively be used. See, for example, FIG. 29 a (sealing lips 47 and48), FIG. 29 b (sealing lips 46 and 49), FIG. 29 c (sealing lips 48 and49) and FIG. 29 d (sealing lips 46 and 47). Other configurations ofsealing lips and retention lips can also be used. This configurationseparates the sealing function of cushion to frame from the functions ofcushion and frame engagement and retention, so that each may beindependently controlled and optimised in device configuration andfabrication.

FIGS. 32 a-1-32 c-2 show sequential engagement between the frame 20 andthe cushion, according to another embodiment of the present invention.In this embodiment, the side wall 215 has been changed, as well as thechannel 26 which receives the side wall 215. FIGS. 32 a-1-32 a-2 showthe frame and cushion before engagement, FIGS. 32 b-1-32 b-2 show theframe and cushion during engagement and FIGS. 32 c-1-32 c-2 show theframe and cushion in full engagement.

In this embodiment, the side wall 215 preferably includes an integrallug 215 a at a distal end of the side wall 215. The side wall 215includes an undercut 215 b which allows the lug 215 a to flex toward theside wall 215. During insertion (FIGS. 32 b-1-32 b-2), the lug 215 aflexes into the undercut 215 b until it is pushed beyond a protrusion 26a in the channel 26. After passing the protrusion 26 a, the lug 215 aflexes into a space of the channel 26 below the protrusion 26 a.Therefore, the tip of the lug is positioned to be resiliently locked inplace with the cushion 40 fully and securely connected to the frame 20.In the connected condition, the side wall 215 provides a secure sealwith the frame 20 against escape of pressurized gas from the nasalcavity. Engagement between the tip of the lug 215 a and the protrusion26 a provides a retaining force to maintain the cushion in engagementwith the frame. To disengage, the patient pulls the side wall 215 out ofthe channel 26 with a force sufficient to cause the lug 215 a to deformand overcome the protrusion 26 a. Both engagement and disengagementrequire a force that is enough to overcome the frictional contactbetween the walls of the channel 26 and side wall 215. As the angle ofprotrusion 26 a is substantially away from the insertion direction, itacts in much the same way as a “barb” allowing the preferred lowerinsertion force compared to disassembly force of the cushion to maskframe.

In the illustrated embodiment, the lug 215 a at the distal end of theside wall 215 extends generally inwardly towards the breathing cavity ofthe cushion. However, as shown in FIG. 32 e, the lug 215 a may extendgenerally outwardly from the breathing cavity of the cushion 40 andengage a protrusion 26 a provided on the outer wall 30 of the frame 20.

FIGS. 40-41 illustrate another embodiment of the frame 20 that isstructured to facilitate the engagement between the frame 20 and thecushion 40. Specifically, the main body 20 a of the frame includesalignment symbols A₁, e.g., diamonds, lines, colors, arrows, etc., onthe outer surface of the outer wall 30 thereof. FIG. 40 illustrates asingle alignment symbol A₁ provided on an upper portion of the outerwall 30 and FIG. 41 illustrates a pair of alignment symbols A₁ providedon a lower portion of the outer wall 30.

The cushion 40 includes alignment symbols A₂, e.g., diamonds, lines,colors, arrows, etc., on the outer surface thereof that are positionedto align with the alignment symbols A₁ provided on the frame 20 when thecushion 40 and frame 20 are engaged with one another. FIGS. 38B, 39B,and 42 illustrate a single alignment symbol A₂ provided on the outersurface of the cushion 40 in the nasal bridge region and FIG. 43illustrates a pair of alignment symbols A₂ provided on the outer surfaceof the cushion 40 in the lip region. When the cushion 40 and frame 20are engaged with one another, the alignment symbol A₁ on the upperportion of the frame 20 aligns with the alignment symbol A₂ in the nasalbridge region of the cushion 40. Similarly, the pair of alignmentsymbols A₁ provided on the lower portion of the frame 20 align with thepair of alignment symbols A₂ in the lip region of the cushion 40. Thealignment of the alignment symbols A₁, A₂ on the frame 20 and cushion40, respectively, ensures that the frame 20 and cushion 40 are correctlyaligned and oriented with respect to one another. That is, the patientcan correctly engage the frame 20 and cushion 40 by ensuring that thealignment symbols A₁, A₂ on the frame 20 and cushion 40 are correctlyaligned with one another.

The alignment symbols A₁, A₂ may have any suitable configuration, e.g.,diamonds, lines, colors, arrows, etc. Also, any corresponding number ofalignment symbols A₁, A₂ may be provided on the frame 20 and cushion 40.In the illustrated embodiment, the upper portion of the frame 20 and thenasal bridge region of the cushion 40 have a different number ofalignment symbols A₁, A₂ than the lower portion of the frame 20 and thelip region of the cushion 20. However, the upper and lower portions ofthe frame 20 and the respective nasal bridge and lip regions of thecushion 40 may have the same number of alignment symbols A₁, A₂ so longas the alignment symbols A₁, A₂ are positioned to facilitate correctlyengaging the frame 20 and the cushion 40 in the correct orientation.Further, the alignment symbols A₁, A₂ may be positioned at any suitablelocation along the outer surfaces of the frame 20 and the cushion 40 tofacilitate the engagement between the frame 20 and the cushion 40.

As shown in FIG. 40, the frame 20 may include alignment symbols A₁,e.g., diamonds, lines, colors, arrows, etc., on the side frame members20 b which are structured to facilitate the engagement between the frame20 and the headgear assembly 80. Specifically, the locking clip 82 ofthe headgear assembly 80 may include alignment symbols, e.g., diamonds,lines, colors, arrows, etc., on the outer surface thereof that arepositioned to align with the alignment symbols A₁ provided on the frame20 when the locking clip 82 and frame 20 are engaged with one another.

Other Aspects

A nasal cushion was designed taking into account the shape and size ofthe nose of the patient, along with the size and shape of thesurrounding facial features, such as the upper lip, the cheeks, etc. SeeFIGS. 30-31. While there is little statistical information regarding thesizes and shapes of those patients likely using or in need of some sortof NPPV treatment, Applicants have discovered that a select amount ofcriteria can be used to statistically model the cushion 40 to fit a vastmajority of the patient population (e.g., 80% of the patientpopulation). For example, the cushion 40 may be structured toaccommodate 60-90% of patient population, regardless of age, sex, orrace. However, the cushion 40 may be structured to accommodate up to 70%or up to 80% of patient population, for example. Using nasal width,nasal tip protrusion and nose height, Applicants have been able todesign the cushion such that a large proportion of the population likelyto be in need of nasal masks can be accommodated comfortably with thesame sized cushions/masks. One or two additional cushions/masks can bedesigned to accommodate other parts of the population. Age, race and sexof the patient can be factors in computer modeling the cushion.Moreover, by designing a cushion in which contact with the upper portionof the nasal bridge portion is avoided, Applicants have been able toeliminate one of the factors which limits the designs of cushions ingeneral.

As shown in FIGS. 30 and 31, the nasal width determines the width of theopening in the cushion 40. Nasal tip protrusion describes minimum depthof cushion and mask frame combined. This is measured from the bottom ofthe septum. A mask with too much depth may result in excessive deadspace within the nasal cavity that increases undesirable CO₂re-breathing and movement of the center of gravity of the mask assemblyfurther away from the face decreasing stability. Nose height reflectsthe distance between both sets of width/depth dimensions.

In general, cushions are sized to fit one or more maximum dimensions.However, user testing is important in verifying clearance at the nasalvent. If too large, the cushion may interfere with the eye area. Thecushion is designed to sit low on the nasal bridge; possibleinterference in this area is minimized. If the cushion is too small,e.g., if the cushion applies pressure along the soft part of the nosethat may collapse, the nasal vent may be partially or fully occluded,causing breathing restriction, as can occur with some prior art maskssuch as the Respironics Simplicity mask. Nose width, height and tipprotrusion can be arrived at by reference to anthropometric data tables.

In one embodiment of the mask system, the mask system is designed toinclude a frame and a plurality of cushions that are each connectablewith the frame. Each cushion would be configured to accommodate apercentage of the patient population such that the plurality ofcushions, preferably 1-3 cushions, would together accommodate up to95-100% of the patient population.

Thus, the plurality of cushions would each have a similar framecontacting side but a different face contacting side. Each cushion wouldhave at least one parameter on the face contacting side that isdifferent from the remaining plurality of cushions. In one embodiment,each cushion may differ in the nasal bridge region. For example, thecushion 40 a shown in FIGS. 38A-38D has a deeper contoured notch 255 ain the nasal bridge region than the contoured notch 255 b in the nasalbridge region of the cushion 40 b shown in FIGS. 39A-39D. Specifically,the contoured notch 255 a has a depth d in the range of 22-27 mm,preferably 24 mm and the contoured notch 255 b has a depth d in therange of 19-23 mm, preferably 21.5 mm. As illustrated, the notch 255 ahas a smaller radius of curvature than the radius of curvature of notch255 b. In another embodiment, each cushion may differ in the width ofthe aperture of the membrane. The plurality of cushions may be colorcoded to help distinguish the different cushions from one another.

Appendix A of incorporated U.S. Provisional Application of Moore et al.,Ser. No. 60/402,509, includes various pictures of the mask systemaccording to one preferred embodiment of the present invention. AppendixA also includes various pictures of the mask system according to otherembodiments of the present invention. For example, an embodiment of theframe is provided that illustrates a frame having oxygen or pressureports. See, e.g. FIG. 41. Further details of oxygen or pressure ports ina frame are included in U.S. patent application Ser. No. 09/504,234, theentirety of which is hereby incorporated by reference. Appendix A alsoincludes instructional information for the mask system. Appendix B ofincorporated U.S. Provisional Application of Moore et al., Ser. No.60/402,509, includes pictures of two prior art masks discussed in thepresent invention. Appendix C of incorporated U.S. ProvisionalApplication of Moore et al., Ser. No. 60/402,509, includes pictures oftwo testing models (A+B) with widely varying nose and facial features,and the mask assembly of the present invention as well as one prior artmask connected to each model. Appendix C also includes a series ofpictures comparing one embodiment of the present invention to a priorart cushion used for the MIRAGE® mask. See, e.g., U.S. Pat. No.6,112,746 to Kwok et al., incorporated herein by reference. Generallyspeaking, the mask assembly of the present invention generally conformedto both nose models even though the sizes and shapes were vastlydifferent. The mask cushion 40 also was able to successfully accommodatethe deformity on model B. The mask assembly of the prior art tended notto fit the shape of the nose models, especially the shape of the smallernose model where significant gaps are seen. One prior art model (seeU.S. Pat. No. 5,724,965) was relatively unstable and tended to rock onthe cheeks of the models, especially the smaller nose model.

It is intended that the components, elements and features of the variousabove-described embodiments can be used together in any desiredcombination or permutation to create new mask embodiments. For example,while the invention has been described in relation to a nasal mask, theteachings are also applicable to oro-nasal and full-face masks as well.

1. A nasal pillows assembly for nasal CPAP therapy of a patientcomprising: (i) a frame including a first alignment indicator, anaperture and a channel having an inner wall, an outer wall and a channelfloor; (ii) silicone nasal pillows selectively and repeatedly attachableto and detachable from the frame, the seal having a face-contacting sideand a non-face contacting side, the non-face contacting side beingengagable between the inner and outer walls of the frame, the nasalpillows including a second alignment indicator on an outer surface ofthe nasal pillows adapted to align with the first alignment indicator onthe frame as the cushion and frame are engaged with one another; (iii) arotatable elbow adapted to engage the aperture provided in the frameincluding one or more vent openings open to atmosphere for gas washoutof exhaled carbon dioxide, the elbow assembly being adapted to connectto a gas delivery tube in order to supply pressurized air to theentrance of the patient's airway; and (iv) a headgear assembly toprovide added stability to the nasal pillows including a pair of frontstraps having a layered fabric and foam structure and having attached bystitching thereto at least one yoke portion, each said yoke portionbeing constructed of a somewhat rigid material and having a relativestiffness that helps to position the frame and nasal pillows in thecorrect position on the patient, each said yoke portion being narrowerthan each front strap so that when the yoke portion and strap areattached together the softer material of the front straps extends beyondthe more rigid material of the yoke portion, thereby preventing or atleast reducing the opportunity for contact between the patient and themore rigid material of the yoke portion, the yoke portion being furtheradapted to add to the rigidity of the straps in certain planes anddirections to assist in stabilizing the nasal pillows assembly on thehead of the patient during use, and when fitted the front end of theyoke portion is connected to the frame below the patient's eyes.
 2. Theassembly of claim 1, wherein the thickness of the yoke portion variesacross its profile to modify the flexibility characteristics.
 3. Theassembly of claim 1, wherein the width of the channel between theupstanding surfaces of the inner and outer walls that face each other isin the range of about 2-10 mm.
 4. The assembly of claim 1, wherein thefirst alignment indicator includes an arrow.
 5. The assembly of claim 1,wherein the channel forms a groove of a tongue and groove arrangement.6. The assembly of claim 1, not including a forehead support.
 7. Theassembly of claim 1, wherein the yoke has a thickness in the range of0.3 to 2 mm.
 8. The assembly of claim 1, wherein the headgear furtherincludes strap structure adapted to engage the occiputal portion of thepatient's head.
 9. The assembly of claim 8, wherein a lower strap of thestrap structure engages a lower region of the occiputal portion of thepatient's head.
 10. A nasal mask assembly for nasal CPAP therapy of apatient comprising: (i) a mask frame including a first alignmentindicator, an aperture and a channel having an inner wall, an outer walland a channel floor; (ii) a silicone nasal seal having a face-contactingside and a non-face contacting side, the non-face contacting side beingengagable between the inner and outer walls of the frame in a mannerthat allows the nasal seal to be repeatedly detachable from andre-attachable to the frame, the nasal seal including a second alignmentindicator on an outer surface of the nasal seal that aligns with thefirst alignment indicator of the frame as the nasal seal and the frameare engaged with one another; (iii) an elbow rotatably coupled to theframe and adapted to connect to a gas delivery tube in order to supplypressurized gas to the entrance of the patient's airway via the apertureof the frame, the elbow including one or more vent openings open toatmosphere for washout of patient exhalation gases; and (iv) a headgearassembly to generally secure the frame and nasal seal to the patient'shead, said headgear assembly including a pair of relatively flexible,generally Y-shaped straps having a relatively soft fabric and foammaterial construction, and a stiffening support structure made of arelatively rigid material compared to the strap material, saidstiffening support structure being stitched to an outside surface of atleast a front portion of the pair of straps, said stiffening supportstructure providing added stability to the nasal seal on the patient'sface in use, said stiffening support structure being narrower than thestrap portion to which it is stitched so that when the stiffeningsupport structure and strap are attached together the relatively softermaterial of the strap extends beyond the relatively rigid material ofthe stiffening support structure, thereby preventing or at leastreducing the opportunity for contact between the patient and therelatively rigid material of the stiffening support structure in use.11. The nasal mask assembly of claim 10, said nasal mask assembly nothaving a forehead support.
 12. The nasal mask assembly of claim 11,wherein the stiffening support structure is constructed from a plasticmaterial and has a thickness in the range of about 0.3 mm to about 2.0mm.
 13. The nasal mask assembly of claim 10, wherein the stiffeningsupport structure forms a connection with the frame and, when fitted, afront end of the stiffening support structure is connected to the framebelow the patient's eyes.
 14. The nasal mask assembly of claim 10,wherein the nasal seal comprises nasal pillows.
 15. A headgear assemblyfor securing a mask frame and nasal seal of a nasal mask assembly to apatient's head, said headgear assembly including a pair of relativelyflexible, generally Y-shaped straps having a relatively soft fabric andfoam material construction, and a stiffening support structure made of arelatively rigid material compared to the strap material, saidstiffening support structure being stitched to an outside surface of atleast a front portion of the pair of straps, said stiffening supportstructure providing added stability to the nasal seal on the patient'sface in use, said stiffening support structure being narrower than thestrap portion to which it is stitched so that when the stiffeningsupport structure and strap are attached together the relatively softermaterial of the strap extends beyond the relatively rigid material ofthe stiffening support structure, thereby preventing or at leastreducing the opportunity for contact between the patient and therelatively rigid material of the stiffening support structure in use.16. The headgear assembly of claim 15, said headgear assembly not havinga forehead support.
 17. The headgear assembly of claim 16, wherein thestiffening support structure is constructed from a plastic material andhas a thickness in the range of about 0.3 mm to about 2.0 mm.
 18. Theheadgear assembly of claim 17, wherein said plastic material is nylon orpolypropylene.
 19. The headgear assembly of claim 15, wherein thestiffening support structure is adapted to form a connection with theframe and, when fitted, a front end of the stiffening support structureis connected to the frame below the patient's eyes.
 20. A nasal maskassembly for nasal CPAP therapy of a patient comprising: (i) a maskframe including an aperture; (ii) a silicone nasal seal having aface-contacting side and a non-face contacting side, the non-facecontacting side being engagable with the frame in a manner that allowsthe nasal seal to be repeatedly detachable from and re-attachable to theframe; (iii) an elbow coupled to the frame and adapted to connect to agas delivery tube in order to supply pressurized gas to an entrance ofthe patient's airway via the aperture of the frame, the elbow includingone or more vent openings open to atmosphere for washout of patientexhalation gases; and (v) a headgear assembly to generally secure theframe and nasal seal to the patient's head, said headgear assemblyincluding a pair of soft and flexible generally Y-shaped straps, and astiffening layer attached to an outside surface of a portion of the pairof straps resting against the cheek regions in use, said stiffeninglayer providing added stability to the nasal seal on the patient's facein use, said stiffening layer having a width that is narrower than thestrap portion to which it is attached so that when the stiffening layerand strap are attached together the soft material of the strap extendsbeyond the stiffening layer, thereby preventing or at least reducing theopportunity for contact between the patient's cheek and the stiffeninglayer in use.
 21. The nasal mask assembly of claim 20, wherein thestiffening layer is constructed from a plastic material which isrelatively more rigid than the soft material of the strap and has athickness in the range of 0.3 mm to 2.0 mm.
 22. The nasal mask assemblyof claim 21, wherein the plastic material is chosen from the groupconsisting of nylon and polypropylene.
 23. The nasal mask assembly ofclaim 20, wherein the straps are made of laminated fabric and foam. 24.The nasal mask assembly of claim 20, wherein the thickness of thestiffening layer varies across its profile to modify flexibilitycharacteristics.
 25. A headgear assembly for securing a mask frame andnasal seal of a nasal mask assembly to a patient's head, said headgearassembly including a pair of soft and flexible generally Y-shapedstraps, and a stiffening layer attached to an outside surface of aportion of the pair of straps resting against the cheek regions in use,said stiffening layer providing added stability to the nasal seal on thepatient's face in use, said stiffening layer having a width that isnarrower than the strap portion to which it is attached so that when thestiffening layer and strap are attached together the soft material ofthe strap extends beyond the stiffening layer, thereby preventing or atleast reducing the opportunity for contact between the patient's cheekand the stiffening layer in use.
 26. The headgear assembly of claim 25,wherein the stiffening layer is constructed from a plastic materialwhich is relatively more rigid than the soft material of the strap andhas a thickness in the range of 0.3 mm to 2.0 mm.
 27. The headgearassembly of claim 26, wherein the plastic material is chosen from thegroup consisting of nylon and polypropylene.
 28. The headgear assemblyof claim 27, wherein the straps are made of laminated fabric and foam.29. The headgear assembly of claim 25, wherein the thickness of thestiffening layer varies across its profile to modify flexibilitycharacteristics.
 30. A nasal mask assembly for nasal CPAP therapy of apatient comprising: (i) a frame including a first alignment indicator,an aperture and a channel having an inner wall, an outer wall and achannel floor; (ii) a silicone nasal seal selectively and repeatedlyattachable to and detachable from the frame, the seal having aface-contacting side and a non-face contacting side, the non-facecontacting side being engagable between the inner and outer walls of theframe, the nasal seal including a second alignment indicator on an outersurface of the nasal seal adapted to align with the first alignmentindicator on the frame as the seal and frame are engaged with oneanother; (iii) a rotatable elbow provided to the frame and including oneor more vent openings open to atmosphere for gas washout of exhaledcarbon dioxide, the elbow being adapted to connect to a gas deliverytube in order to supply pressurized air to the entrance of the patient'sairway; (iv) a headgear assembly including relatively flexibleheadstraps; and (v) a stiffening support structure extending from theframe to assist in the stabilization of the nasal seal, the stiffeningsupport structure being formed of a relatively more rigid material incomparison to the relatively flexible headstraps, said stiffeningsupport structure having a degree of flexibility in one direction suchthat variations in patient physiology can be accommodated, saidstiffening support structure being stiffer in another directiongenerally orthogonal to the one direction to resist vertical rotation ofthe frame due to the weight of the mask frame and/or componentssupported by the frame, said stiffening support structure arranged to bepositioned adjacent the cheek regions in use, said stiffening supportstructure having on an inside surface thereof, a layer of relativelysoft and flexible material arranged between the patient's cheek and thestiffening support structure in use, and said layer of relatively softand flexible material having the same general shape as the stiffeningsupport structure.
 31. The nasal mask assembly of claim 30 wherein thelayer of relatively soft and flexible material is attached to thestiffening support structure by stitching.
 32. The nasal mask assemblyof claim 30 wherein the stiffening support structure is constructed froma plastics material having a thickness in the range of 0.3 mm to 2.0 mm.33. The nasal mask assembly of claim 32 wherein the stiffening supportstructure is constructed from nylon or polypropylene.
 34. The nasal maskassembly of claim 30 wherein a top end of the stiffening supportstructure includes a connector element adapted to connect with a freeend of one of the headstraps.
 35. The nasal mask assembly of claim 34wherein the connector element includes a crossbar.
 36. The nasal maskassembly of claim 35 wherein in use the free end of the headstrap isadapted to be threaded around the crossbar.
 37. The nasal mask assemblyof claim 36 wherein the free end of the headstrap is adapted forlengthwise adjustment by threading through the connector element of thestiffening support structure.
 38. The nasal mask assembly of claim 30,wherein the silicone nasal seal comprises nasal pillows.
 39. The nasalmask assembly of claim 30, wherein the headgear assembly includes onlytwo connection points to support the frame.
 40. The nasal mask assemblyof claim 39, without a forehead support and without obstructing thepatient's field of view.
 41. A nasal mask assembly for nasal CPAPtherapy of a patient comprising: (i) a frame including a first alignmentindicator, an aperture and a channel having an inner wall, an outer walland a channel floor; (ii) a silicone nasal seal selectively andrepeatedly attachable to and detachable from the frame in such a mannerthat, upon engagement, the seal forms a secure seal with the frame andis retained in releasable engagement with the frame without anadditional retaining device, the seal having a face-contacting side anda non-face contacting side, the non-face contacting side being engagablebetween the inner and outer walls of the frame, the nasal seal includinga second alignment indicator on an outer surface of the nasal sealadapted to align with the first alignment indicator on the frame as theseal is fitted to the frame; (iii) a rotatable elbow provided to theframe and including one or more vent openings open to atmosphere for gaswashout of exhaled carbon dioxide, the elbow being adapted to connect toa gas delivery tube in order to supply pressurized air to the entranceof the patient's airway; (iv) a headgear assembly including relativelyflexible headstraps; and (v) a stiffening support structure to assist inthe stabilization of the nasal seal, the stiffening support structurebeing formed of a relatively more rigid material in comparison to therelatively flexible headstraps, said stiffening support structurearranged to be positioned adjacent the cheek regions in use, saidstiffening support structure having on an inside surface thereof, alayer of relatively soft and flexible material arranged between thepatient's cheek and the stiffening support structure in use, wherein anend of the stiffening support structure, remote from the frame, includesa connector element adapted to be coupled with a free end of one of theheadstraps, wherein the connector element is formed in one piece withthe stiffening support structure and includes a crossbar, and whereinthe free end of the one of the headstraps includes a strap loop wrappedaround the crossbar.
 42. The nasal mask assembly of claim 41 wherein thelayer of relatively soft and flexible material is attached to thestiffening support structure by one or more rows of stitching.
 43. Thenasal mask assembly of claim 41 wherein the stiffening support structureis constructed from a plastics material having a thickness in the rangeof 0.3 mm to 2.0 mm.
 44. The nasal mask assembly of claim 43 wherein thestiffening support structure is constructed from nylon or polypropylene.45. The nasal mask assembly of claim 41 wherein the free end of theheadstrap is adapted for lengthwise adjustment by threading through thecrossbar of the stiffening support structure.
 46. The nasal maskassembly of claim 41, wherein the silicone nasal seal comprises nasalpillows.
 47. The nasal mask assembly of claim 41, wherein the headgearassembly includes only two connection points to support the frame. 48.The nasal mask assembly of claim 47, without a forehead support andwithout obstructing the patient's field of view.